Bringing the pregnancy test home from the hospital

A fertile environment

To understand the introduction of the home pregnancy test and the process of juris-technical accordance that ensued, it is important to understand the history of the device and its contexts.

In early 1978, readers of several women’s magazines in the US learned of a technology that was becoming widely available – the home pregnancy test (Layne, 2009; Leavitt, 2006). Along with the thermometer and the bathroom scale, the home pregnancy test has since become one of the most widely used technologies of self-diagnosis in American history. The home pregnancy test, however, was not yet in the American marketplace and was barely known. It was unregulated throughout much of the 1970s, though not without contest. Despite the fit in some rhetorical frameworks of the era, the test’s ability to accord with both a changing regulatory framework and a changing relationship between a woman and her doctor would determine its place in American social life.

For most of the 20th century, delivering pregnancy news, or any reproductive news, was the exclusive domain of medical professionals. Dr Alan Guttmacher, perhaps the most well known family planning advocate of the late 20th century, wrote in 1964,

One of a physician’s happy tasks is to confirm a pregnancy for a man and wife who eagerly await good news. I have enjoyed making this announcement hundreds of times. But on other occasions I have had to announce the same news to women, and their husbands, who were afraid and shocked to hear it. I have not yet devised a formula for remaining aloof from unhappiness about an unwanted pregnancy, or a way to handle these pathetic situations with the grace I feel they deserve. (p. 106)

The 1960s and 1970s saw monumental shifts in the relationships of women’s bodies to the state, but doctors, particularly obstetricians and gynecologists, remained critical actors. In Griswold v. Connecticut (1965), for instance, a married couple challenged a 19th-century Connecticut law prohibiting the use of contraceptives. The Supreme Court struck down the law, holding that it ‘operates directly on an intimate relation of husband and wife and their physician’s role in one aspect of that relation’ (Griswold v. Connecticut, 1965), and thus the law violated the First Amendment’s ‘penumbra where privacy is protected from governmental intrusion’. While the government was banished from the marital bedroom under Griswold, the couple’s doctor still had a permissible role. On one hand, the state’s sexual moral authority was being challenged and redefined, but on the other, state objectives could still be exercised to some degree through doctors.

The medical profession increasingly lost social authority in the 1970s, due in part to the growing direct and social costs of health care. Women’s health activists, who saw the medical profession as sexist and paternalistic, sought ‘to … “demedicalize” critical life events, such as childbirth’, and as such, some activists sought to take medicine ‘into their own hands’ (Starr, 1982: 391). The central tenets of the women’s health movement included self-knowledge, individual choice, and individual responsibility (Morgen, 2002). Activists in the movement demanded greater control over their bodies, including knowledge, choices and alternatives to mainstream medical care. In a popular women’s health movement booklet, Complaints and Disorders: The Sexual Politics of Sickness, Barbara Ehrenreich and Deirdre English (1973) wrote,

The medical system is not just a service industry. It is a powerful instrument of social control … The medical system, more than any other institution of American society, reduces us to our biological category, stripped of our occupations, life styles, and individualities. (pp. 83, 85)

The self-help movement, as a smaller part of the broader women’s liberation and women’s health movements, focused on personal, micro-level control. ‘Self help, which emphasized self-examination and self-knowledge, is an attempt to seize the technology without buying the ideology’ (Ehrenreich and English, 1973: 84, italics in original). The home pregnancy test fit perfectly into the rhetorical paradigm that the women’s health movement developed and promoted. Nevertheless, while the self-help movement flourished in the 1970s and diminished in the 1980s, home pregnancy tests were surprisingly not mentioned until the 1984 edition of the classic self-help text Our Bodies, Ourselves (Boston Women’s Health Collective, 1976, 1979, 1984). Home pregnancy tests are not examined in a thorough contemporaneous ethnography of the movement (Ruzek, 1978). Thus, the home pregnancy test was never a central technology for the movement in the same way as were the Pill and menstrual extraction kits. Clinical pregnancy testing did, however, flourish in women’s health clinics of the 1970s as one of the basic services offered to patients, along with birth control, abortion, and pregnancy counseling (Morgen, 2002).

Meanwhile, 1973 marked the legalization of abortion in the first and second trimesters of pregnancy in the landmark case Roe v. Wade (1973). While states had less direct authority over women’s reproductive choices, doctors necessarily became mediators between the state and women, both in the determination of gestational age as well as the providers of various services such as abortions and counseling. Roe had a tremendous impact on the way women understood their reproductive rights, and the case played a role in the way people ‘organized intimate relationships and made choices that define their views of themselves and their places in society’ (Planned Parenthood v. Casey, 1992). Regardless of an individual woman’s stance on abortion, all American women were well aware of the implications of Roe, and women and doctors arranged their roles and personal lives accordingly.

The changing legal framework of women’s reproductive rights, the women’s health movement, and the challenges to medical authority and cost of care all provided a legal and social framework in which to rhetorically and practically fit a do-it-yourself test for pregnancy. Though not directly advocated in any of these various contexts, the adoption of the home pregnancy test was facilitated by its compatibility with many of the social changes of the era.

Technological innovation and regulatory lag

How can the public be protected from potential risks posed by technologies that do not yet exist? Can rules be written to contain future technological risks without being over-reaching and burdensome? Major and minor technological advances that are truly novel can fall outside of the imaginative scope of lawmakers.

Early 20th-century reproductive endocrinology research was a value-laden endeavor to find a root cause of sex differences between women and men. As Oudshoorn (1994) has shown, the development of female sex endocrinology was highly dependent on an asymmetrical organizational structure that made the female body, and not the male body, the central focus of hormone research and innovation. This century-old research has in its genealogy, among many other technologies, the Pill, Norplant, and in vitro fertilization. This lineage of reproductive endocrinology also produced the earliest reliable human pregnancy tests.

From 1928 through 1960, pregnancy testing required in vivo tests on a live animal. ‘The only practical difficulty in the adoption of the test’, it was noted of the rabbit test in 1929, ‘is the need of a suitable supply of test animals under the care of an expert’ (Johnstone, 1929: 264). Using live animals was costly, cumbersome, and required the use of laboratories prepared to house and dissect the animals (Hunt, 1975). Immunoassays merely required antibodies to react with another substance. The first in vitro immunoassay for pregnancy was developed in 1960 by Leif Wide, Daniel Mishell, and Carl Gemzell in Uppsala, Sweden, who recognized that not only was the immunoassay more accurate, but it was far less tedious and expensive than the use of live animals (Mishell et al., 1963; Wide and Mishell, personal communications). The immunoassay developed by the Swedish and American researchers in Uppsala reported pregnancy or lack thereof with a hemagglutination test – an agglutination of red blood cells of a sheep in a simple test tube. Pregnancy testing moved from in vivo tests to in vitro tests very quickly and hemagglutination immunoassays to determine pregnancy quickly became the laboratory standard.

Because the tests required the addition of several chemicals to test tubes in a precise manner, however, the tests remained laboratory tests for most of the 1960s. Meg Crane, a graphic designer working on cosmetics for Organon in West Orange, NJ, saw the laboratory tests in 1967 and suggested to a company executive that women could do the tests themselves. The executive responded that it wouldn’t work because Organon would ‘lose our doctor business’, so she tinkered at home with office supplies to make the design work (Crane, personal communication). Enthusiasm from Organon’s headquarters in the Netherlands allowed her project to go forward. In 1971, Organon attorneys patented the design under Crane’s name, and Organon bought the patent from her for US$1. By the end of the decade, hemagglutination home pregnancy tests were sold to women in Canada and Europe, but the tests was not available to women in the US (Cohn, 1970). In January 1971, one hemagglutination test, Confidelle (Princeton Laboratories, NJ and Denver Laboratories, Canada, Ltd.), was available in Canadian pharmacies and may have made it to a small US market, but the evidence for this is unclear, and in any case its availability or impact was barely noticed by American medical and public health professionals (Field, 1971; Hunt, 1975).

In August 1971, Faraday Laboratories of New Jersey announced to investors its new home pregnancy test, and by late 1971 it was selling ‘Ova II’ to American consumers under the tagline, ‘When you want to be the first to know’ (Hershey, 1971). Ova II, the first home pregnancy test to be available to US consumers, was a hemagglutination test tube test ‘identical’ to those that were used in laboratories (Shapiro et al., 1976), and it purported to be reasonably accurate in the determination of pregnancy even when used by laypeople (Hunt, 1975). In part because of the device’s novelty, it was not immediately clear to manufacturers or regulators what kind of thing a pregnancy test was. And before answering the question of whether the device posed a risk to the public, it was necessary to answer a still more basic question: Is pregnancy a disease? This question proved central to the controversy that ensued. Faraday’s sale of Ova II to the public challenged the FDA’s right to regulate a wide variety of in vitro home diagnostics. This challenge of innovation to existing regulation marks the first stage in the process of juris-technical accordance.

The sale of the home pregnancy test to the public brought to light larger debates about the US government’s ability to regulate risk. The Food, Drug, and Cosmetic Act of 1938 both created the FDA and gave it a tremendous and unique power. The FDA’s power lies in its ability to regulate, or subject to veto, a wide variety of products before they enter the market. Carpenter (2010) shows that through this premarket, or ex ante power, the FDA is able to wield tremendous regulatory power over many aspects of social life. This ex ante power is freely exercised and typically unchallenged, despite the agency’s relatively meager budget and location in a country notoriously distrustful of government.

From its creation, the FDA could regulate or veto what were classified as ‘drugs’ before they were marketed or sold to the public. The agency could only regulate non-drug products after they had been sold to consumers and had proven extremely harmful. Thus, industrial manufacturers of medical devices could often avoid the cost of FDA scrutiny, and over the next twenty-five years, a wide variety of medical products entered the marketplace that the FDA did not have the power to regulate before they entered the market.

By the late 1960s, medical professionals and the public at large were increasingly concerned with the growing field of medical devices. Many argued that new legislation would be necessary to combat the risks associated with devices, just as drugs had been regulated before them. In 1969, however, the Supreme Court seemed to say otherwise. In United States v. Bacto-Unidisk (1969), the Court held that a small disc that never touched the body, used by medical professionals to determine which antibiotic should be used to treat an individual’s disease, to be a ‘drug’ and therefore subject to premarket regulation by the FDA. Through the decision to classify Bacto-Unidisk as a ‘drug’, the Supreme Court extended the FDA’s jurisdiction over in vitro diagnostic devices.

The case was merely a temporary solution to the general lack of regulatory authority of the FDA over devices, and despite the holding in favor of the FDA, Bacto-Unidisk drew attention to the meager regulatory framework. In 1970, President Nixon called for greater regulation of devices, and through the Department of Health, Education, and Welfare formed the Cooper Committee to write recommendations to modify the FDA framework (Rados, 2006). Over the next several years, Congress and the President were deeply involved in Vietnam and Watergate. In such circumstances, updating the federal government’s regulations to include medical devices was not a priority. This regulatory lag had significant implications for American women in the years to come.

Is pregnancy a disease? Regulatory creep and the limits of FDA jurisdiction

Meanwhile, the FDA remained at work under the Bacto-Unidisk holding. A variety of medical devices nevertheless flooded the market, and the FDA did its best to keep up with postmarket regulation based upon a device’s harm. The FDA attempted another tactic to buttress its weak jurisdiction over in vitro diagnostics. In August 1972, it proposed new labeling requirements to cover a wide array of diagnostic ‘test kits’ for use by both doctors and laypeople (Edwards, 1972; UPI, 1972). The FDA located the requirement under its authority to regulate drugs or devices that are used for the diagnosis or prevention of ‘disease’, but within the same paragraph of its proposed rules identified ‘Products for use in the detection of pregnancy’ (Edwards, 1972: 16613) with no apparent awareness of a difference between pregnancy and disease. Henry Simmons, the director of the FDA’s Bureau of Drugs, stated ‘This industry has been unregulated. With this step we will have taken over the regulation of the products in the medical care system’ (UPI, 1972).

Perhaps the public acquiescence to the agency’s bold proposal gave it confidence to assume even greater authority. Just four months later, in December 1972, the FDA took the drastic measure of recalling Ova II, stating that the tests were ‘inaccurate, unreliable, and prone to give false results’ (Lyons, 1972). A spokesperson from Faraday Laboratories countered that the tests were ‘accurate and reliable when used as directed’, but agreed to recall the kits, though the spokesperson questioned the jurisdiction of the FDA to regulate the product premarket because it was not a drug (Baker et al., 1976; Lyons, 1972). Perhaps further preventing FDA action was that under the law at that time, the FDA could recall (postmarket) ‘harmful or ineffective’ devices, which were defined as ‘instruments, apparatus, and contrivances, intended for the diagnosis, cure, mitigation, treatment, or prevention of disease in man or affect the structure or any function of the body of man or other animals’ (USC, 1972: 21 USC §321(h), emphasis added). It was particularly notable that the FDA recalled Ova II, because it had questionable regulatory power over such products and a limited budget with which to do so.

August 1974 marked both the resignation of President Nixon and, less notably, reputational strife at the FDA. Congressional hearings led by Senator Ted Kennedy found that the FDA had been ‘less adversarial toward and more cooperative with drug manufacturers’, in particular, by demoting and transferring medical officers who were less favorable to the pharmaceutical industry (Carpenter, 2010: 487). FDA Commissioner Alexander Schmidt, a Nixon appointee known for friendliness toward the pharmaceutical industry, became ‘increasingly bound by decisions’ of lower-level employees (Carpenter, 2010: 492).

In this period of general governmental upheaval, Faraday Laboratories decided not to comply with the FDA’s recall, and the FDA sued Faraday in federal court in New Jersey. Fundamentally at issue in the decision, however, was not whether Ova II was safe and effective, but rather whether a home pregnancy test could be classified as a ‘drug’ under the meaning of the law at that time. The Court granted Faraday’s motion for summary judgment on the basis that there were no issues of fact in dispute, merely issues of law. District Judge Vincent Biunno held:

The condition of pregnancy, as such, is a normal physiological function of all mammals and cannot be considered a disease of itself. Pregnancy is an execution of an inherent bodily function and implies no ailment, illness, or disease. Both parties agree that this is so … A test for pregnancy, then, is not a test for the diagnosis of disease. It is no more than a test for news, which may be either good news or bad news depending on whether pregnancy is wanted or not … On the central question, then, the court is satisfied that there is no genuine issue of any material fact, and that Faraday is entitled to judgment as a matter of law. There is no dispute that FDA has the burden of persuasion. Taking each of the three definitions of a ‘drug’, as set out in 21 USC §321(g)(1), it is plain that the Ova II kit does not fall within any of them. (United States v. Article of Drug – OvaII, 1975)

FDA Commissioner Schmidt said of the decision,

It is clear that this decision has far-ranging implications with respect to our ability to assure the safety and accuracy of about 100,000 products used to diagnose and treat a wide variety of medical conditions. (UPI, 1975)

In 1975, the FDA only had the ability to regulate that which could be defined as a ‘drug’, that which was ‘intended for the diagnosis, cure, mitigation, treatment, or prevention of disease’ (USC, 1972: 21 USC §321(h), emphasis added). In an attempt to stretch the meaning of the existing law to encompass this new technology, the FDA had argued that Ova II pregnancy tests were technologically analogous to the Bacto-Unidisk tests because they were in vitro and that they could detect disease. ¹ By finding that pregnancy was not a ‘disease’ and therefore that Ova II was not a ‘drug’ (though Bacto-Unidisk was), Judge Biunno held that the FDA did not have the power to regulate these or any related devices. The FDA attempted to include home pregnancy tests and other in vitro diagnostics in what one might call a regulatory corona, but Judge Biunno’s holding was in line with both the congressional critiques of FDA leadership as well as the women’s health movement, which argued pregnancy and childbirth were normal events and ‘not a disease’ (Starr, 1982: 391). Rather than leaving the science to the scientists and the regulations to the regulators, the judge in this case embraced a ‘holistic conception of law’ and rejected the notion of strict separatism between science and society (Jasanoff, 1995: 219). Moreover, by interpreting the plain meaning of the text, the judge’s decision easily rested on and reinforced Weberian principles of pure legal authority, i.e., public legibility of the law and consistent application of the law.

Interestingly, when pregnancy tests were in the hands of medical professionals, there was never any question about their reliability or safety, but when the tests had the possibility of entering the hands of lay women, they were deemed by the FDA to be ‘inaccurate’, ‘unreliable’ and potentially even ‘harmful’. Judge Biunno held, however, that pregnancy tests were merely tests for news. Like all medical devices – e.g., thermometers, weight scales, etc. – there is always a possibility of error with the device itself, and even if functioning correctly, they can be misused or misunderstood by medical and laypeople alike. It was not clear what harm could come to women if error rates were simply disclosed with the device. What is more clear is that an image of women using chemicals in test tubes in their own homes to determine their own pregnancy, jarred some social groups and social norms more than did other home health devices.

The FDA’s attempted analogy between the new home pregnancy test and prior tests like Bacto-Unidisk failed. Though laws are often written in broad terms to allow for historical developments, some advances, particularly in technology, are unforeseen or unforeseeable. Interpretations of the law depend on which actors have power and how they choose to exert it, as well as on the legal philosophy of particular jurists. Judge Biunno determined that the prior law could not be interpreted to encompass this new technology, marking another stage of juris-technical settlement. This decision provided legal certainty to pregnancy test manufacturers that they could market their product without the fear of regulatory reprisal.

Translating the technical to the public

The decision in US v. OvaII (1975), upheld by the Third Circuit Court of Appeals (1976), ² brought more attention to home pregnancy tests than ever before, particularly because the FDA claimed the test’s inaccuracy rate was very high. The publication and news coverage of OvaII translated the new juris-technical development to the public and defined what was at stake. Laypeople had a right to use pregnancy tests in their own home, without the presence of a medical professional, and the FDA did not have the authority to prevent them from doing so. Without these clearly and legally defined boundaries of individual rights and regulatory authority, the process of translation would have stagnated. Had the law been silent, industrial and financial interests would have faced uncertainty, and wider public understanding and acceptance would have stagnated. The legal decision in OvaII introduced the concept of a home pregnancy test to an American audience, effectively translating the juris-technical issues at stake to the public.

Tests like Ova II, which allegedly lacked reliability when used by laypeople, embodied all that there was to love and fear about home diagnostics. The decision provoked a variety of responses from those in the health and medical communities. There were relatively minor concerns that worried medical professionals, from the device’s ‘shipping and storage problems’ to the ‘relatively high literacy level’ required to understand the instructions (Hunt, 1975: 122). From the perspective of the device’s use, however, opinion was most divided on the issue of reliability (Hunt, 1975). A false positive could, professionals claimed, cause ‘unnecessary psychological stress and expose her to the expense and potential risk of an unnecessary legal or illegal abortion procedure. A false negative … could delay the beginning of prenatal care or an early legal abortion’ (Baker et al., 1976: 167). The concerns generally assume an uneducated and careless user, unable to understand accuracy rates, let alone how to manage chemical reactions in test tubes. Moreover, the user’s ‘psychological stress’ was assumed to be greater when at home than when with a medical professional who was potentially a stranger. It is questionable whether such concerns would have been expressed in the same manner about men, at least in the 1970s.

Others viewed home pregnancy tests as a jurisdictional threat to their profession, just ‘the tip of the iceberg’ (Entwistle, 1976: 1108). There was a concern over lack of sufficient training to detect malfunctions and that a lack of understanding of the chemical reactions involved could impair results. One technologist wrote in the American Journal of Public Health,

I am becoming increasingly worried by the escalating use of such kits by nontechnical staff such as nurses, receptionists, and clerical employees in health centers and in private practice, and especially, as in this case, by the patient herself. (Entwistle, 1976: 1108)

Explicitly, the technologist expressed concern that the reputation of ‘the profession of medical laboratory technology will suffer unless legislation is introduced to limit the use of such potentially dangerous kits to those staff fully trained to use them’ (Entwistle, 1976: 1108). The language is particularly telling. ‘Nurses, receptionists, and clerical employees’ were undoubtedly mostly women, as was, of course, ‘the patient herself’. By invoking highly gendered professions that were assumed to be less technologically savvy, the technologist used stereotypical tropes to denote a lack of competence.

But other medical professionals were more split, and some were even strongly in favor of the tests. Those in favor of the tests often expressed their support with language of knowledge, information, confidentiality, control, and choices – thus using the ‘rights language’ that was in widespread use by the women’s health movement. One writer claimed that ‘[n]early all family planning physicians agree[d] that women have a basic right to information about their own fertility as simply and confidentially as possible, and of course, a do-it-yourself kit provides this’ (Hunt, 1975: 121). Women could be ‘the first to know’ (Baker et al., 1976: 167) and could gain ‘control over their bodies which is their right’ (Oakley, 1976: 502). Women were called on to ‘demand that these products become available over-the-counter so that we are not dependent on medical superstructures for confirmation of our own reproductive choices’ (Oakley, 1976: 502). Those in favor of home pregnancy tests downplayed the importance of accuracy and technical problems by employing the ‘rights’ language of the reproductive health movement. On a practical level, they judged the tests ‘convenient for the user’ and ‘less expensive than laboratory tests’ (Hunt, 1975: 122). Earlier diagnosis could be possible, making possible both earlier prenatal care and earlier abortions (Baker et al., 1976).

Those medical professionals most in favor of the tests said that the issues facing the tests of reliability and complex instructions could be solved by the production of more accurate tests with easy to understand instructions (Stim, 1976a, 1976b). Dr Edward Stim, active in the debate at the time and strongly in favor of the development of the home pregnancy test, agreed that the tests should be ‘scientifically tested by consumer volunteers in a medical setting before being “liberated” on the public’, but worried that

[t]here is more than enough repressive legislation as it is without being further burdened by another law which will prevent consumers of medical services from obtaining access to pregnancy diagnosis and early abortion. (Stim, 1976a: 1109)

Stim’s editorials in the American Journal of Public Health echoed the consumer protectionist tone of the era (Stim, 1976a, 1976b). The editor of the journal agreed with Dr Stim,

[a] falsely interpreted temperature or test for urine sugar might be even more dangerous than a falsely interpreted pregnancy test. Not everyone needs carpenters to hammer in their nails. (American Journal of Public Health [AJPH], 1976)

Ova II, and home pregnancy tests in general, threatened the professional boundaries of various medical professionals, particularly technicians (Gieryn, 1983). By the late 1970s, in addition to a doctor’s office, women could receive a pregnancy diagnosis at little or no cost from one of many hundreds of labs and clinics run by technicians (Consumer Reports, 1978; Leavitt, 2006). The near extinction of those labs and clinics today is revealing. Due to their singular task in the pregnancy testing network, technicians were among those with the most to lose by the tests going home and into the hands of laypeople (Abbott, 1988). Though technicians had education and licensing to perform their tasks, they lacked the institutional backing of medical doctors, and thus their node could easily be replaced. To counteract their own profession’s displacement, technicians sought to distinguish between those who held the necessary technical expertise to achieve accurate results and lay users who allegedly did not.

Classification of risk and reassertion of the FDA’s ex ante power: The Medical Device Amendments of 1976

The 1970s were characterized by favorability toward additional regulation in an otherwise government-wary nation (Starr, 1982). Perceived risks of new consumer technologies, combined with statements that suggest the technology is a threat to social norms or morality, often precede calls for greater government intervention.

By the time of the OvaII ruling, there had been calls for medical device regulation for years, but it was not until 1976 that Congress enacted the recommendations of the Cooper Committee in what are known as the Medical Device Amendments (Rados, 2006). Deaths and injuries from several harmful devices (heart valves and intra-uterine devices, in particular) brought attention to the risks of unregulated devices, and Congress was ready to act. Women’s health movement activists viewed the Medical Device Amendments (MDA) as long-overdue and much-needed regulatory protections (Ruzek, 1978). Perhaps the most important recommendation of the Cooper Committee was that the regulations should be specific enough to regulate a variety of devices in different ways.

In general, the law uses classification as a method to divide and conquer. The concept of division, in particular the separation of people and things into categories, each of which is governed by a particular set of powers and rules, is the fundamental basis of legal jurisdiction. ‘Jurisdiction’, in legal parlance, is the rough equivalent of ‘ability’ or ‘power’ – to have jurisdiction is to be able to function, and to be without jurisdiction is complete impotence. As Jasanoff (1995) elegantly states: ‘The law is called upon to fix the leaky walls between worlds we construe as social and natural, to recreate normative order when previous understandings have been stretched to the fraying point’ (p. 161).

The MDA divides medical devices into three categories: Class I – General Controls (low risk); Class II – Special Controls (moderate risk); and Class III – Premarket Approval (high risk). Class I products were intended to be all products that were not inherently very risky, so did not require more supervision than the controls already in the power of the FDA, such as recalls (if there was evidence that the product caused harm to individuals). Class II products were those products that required more supervision than was already in the power of the FDA, but did not rise to the level where they would always need approval from the FDA before they entered the market. Finally, Class III products were those that were judged to be most risky and deemed potential threats to life.

These three categories were applied to all products available on the market prior to the date of enactment of the law, May 28, 1976. Importantly, a product entering the market after that date would initially be placed in Class III, a very costly classification, unless the device maker could show that it was ‘substantially equivalent’ ³ to a predicate device (USC, 1976: 21 USC §360C(f)(1)). Manufacturers could save tremendous amounts of money if they could show that their devices met the substantial-equivalence test, through a process that has come to be known as 510(k) clearance.

The meaning of substantial equivalence, then, is the primary vehicle for avoiding the regulatory mechanisms that are imposed upon Class III devices. ‘Substantial equivalence’ is defined in the law as

(i) has the same technological characteristics as the predicate device, or

(ii) (I) has different technological characteristics and the information submitted that the device is substantially equivalent to the predicate device contains information, including appropriate clinical or scientific data if deemed necessary by the Secretary or a person accredited under section 360m of this title, that demonstrates that the device is as safe and effective as a legally marketed device, and (II) does not raise different questions of safety and effectiveness than the predicate device. (USC, 1976: 21 USC §360C(i)(1)(A))

Substantial equivalence was a regulatory innovation that was particular to the regulation of devices. Unlike drugs, in which a chemical compound remains fundamentally the same over time, devices are improved upon constantly. Requiring entirely new approvals every time a device had any improvement would render regulation impossible. Substantial equivalence permitted regulators to replace a leaky wall with a formalized porous boundary. Moreover, under different administrations and budgets, the interpretation of substantial equivalence could in theory be interpreted more strictly or loosely. In practice, however, devices have always been regulated less stringently than drugs.

At that time, home pregnancy tests were still in their infancy, and given the fact that Ova II was seen by the FDA as a risky device it is unlikely that other device manufacturers would have sought to use Ova II as their ‘predicate’ device. Nevertheless, the product and its eponymous case had a lasting impact.

Under the OvaII ruling, home pregnancy tests could be marketed without premarket approval. Thus, the pharmaceutical company Warner-Chilcott was permitted to test market its product, e.p.t., before the enactment of the law. Warner-Chilcott was not alone. Indeed, there was ‘enormous interest in getting a device on the market before the law was passed’ because it could avoid premarket controls (Landa, personal communication). As a result, e.p.t. was ‘grandfathered’ under its initial classification (whatever initial classification would apply to it), and companies marketing any ‘substantially equivalent’ devices could apply to have them classified similarly (Bastian et al., 1998; Family Planning Perspectives, 1979: 191). So despite the fact that the Medical Device Amendments extended the FDA’s ex ante power to regulate all medical devices, there was a window of opportunity between OvaII on July 26, 1975, and the enactment of the law on May 28, 1976, within which pharmaceutical companies could sell home pregnancy tests with legal certainty. Warner-Chilcott’s test market during this window took maximum advantage of the regulatory lag and would permit widespread sale and marketing of home pregnancy tests to US consumers.

Restabilizing networks of expertise

E.P.T. Early Pregnancy Test gives women a new power, the power of time to help control the quality of their pregnancies. The first 60…days are critical in fetal development. Improper nutrition, cigarettes, alcohol, even commonly used household medications can be harmful in these crucial first 60…days before most women even know that they are pregnant. Now with E.P.T. you can know. Now, when you call your doctor, you have the results of your test to report. And time is on your side at last. (Vogue, 1978)

Less than two years after its test marketing, and during the period when implementation of the MDA was still being ironed out, e.p.t. became the first home pregnancy test to be marketed widely to American consumers. ⁴ It received much more widespread publicity than its predecessor Ova II, both in the form of paid advertisements and independent newspaper articles. Full-page ads in several women’s magazines showed white, conservatively dressed, and calm-looking women reading the results from one of e.p.t.’s test kits. In some of the ads, a woman wore a wedding ring and was accompanied by a man. Some questioned Warner-Chilcott’s ‘right type’ of consumer. ‘Feminists feel commercials push the proparenthood stereotype, suggesting only white, married women who want to be pregnant become so’, a Los Angeles Times journalist noted (Elvenstar, 1979: OC_C1).

While some were skeptical of the marketing of the test, many doctors were skeptical of the test itself. The American College of Obstetrics and Gynecology, the professional association of those physicians most involved with reproductive medicine, had ‘no objections per se to over-the-counter pregnancy tests, as long as the directions for use are clear and the woman is advised to see a doctor if the results warrant it’ (Brody, 1978: C11). Dr Ervin Nichols, director of practice activities for the ACOG explained, ‘We neither condemn nor applaud the tests. There is no harm in the patient doing the test, but we do have concern for false results’, such as a false positives leading to appointments at ‘a storefront abortionist’ and false negatives during an ectopic pregnancy which ‘could result in death’ (Krucoff, 1979: B5). One journalist who asked several physicians about their opinions of the tests wrote: ‘Although a few did endorse the kit, physicians were generally negative about the idea of home pregnancy testing, and even those who approved had reservations about its use’ (Henderson, 1978: A10). An academic journalist argued, ‘Many members of the established health care system are critical of home testing. For some physicians, it may be a case of threatened hegemony’, as well as the more noble cause of patient well-being (Powledge, 1980: E20). Between 1977 and 1980, articles weighing the merits of home pregnancy tests appeared in The New York Times, The Boston Globe, The Los Angeles Times, the Chicago Tribune, and The Wall Street Journal, as well as many regional papers. A review of all of these articles confirms the contemporary journalists’ findings that doctors had mostly negative views of the tests. ⁵ The doctors’ two primary objections, lack of reliability of the tests and stress affecting the results, were the same as their objections to the prior test, Ova II.

The home pregnancy test was still a hemagglutination test, conducted using a test tube, a dropper, and a chemical additive, slightly more complex than the sandwich assay common today. Many doctors cited the general lack of reliability of the tests. Dr Dan Tulchinsky, a Boston OB-GYN argued: ‘Something can very easily go wrong. Even under laboratory conditions, pregnancy test results vary. False positives occur three to five percent of the time and false negatives are very common’ (McManus, 1978: A20). The medical director of Planned Parenthood of Maryland expressed skepticism that novices would use it correctly. ‘I wouldn’t even trust my reading of a test we do here as much as I would trust a lab technician who has performed the test hundreds of times’ (Henderson, 1978: A10). Dr H. Lorrin Lau of Johns Hopkins ‘has found that even medical students and their wives have difficulty doing their own pregnancy tests accurately’ (Brody, 1978: C11). In a Chicago Tribune medical advice column, ‘How to Keep Well’, Dr G. Timothy Johnson advised readers of his concern regarding the accuracy of the tests, writing that ‘as long as a woman is not hesitant about seeing her doctor, I think his test would be more reliable than these home tests’ (Johnson, 1978: A5). Mary Petronovich of the West Hollywood Women’s Clinic said that the tests were ‘too complex for an average person to use’, but also that ‘any chemical test is invalid without a pelvic exam to back it up’ (Elvenstar, 1979: OC_C1). Overall, doctors expressed a concern that laypeople, inexperienced with laboratory tests, would be equally or more likely to receive inaccurate results.

There was also a general concern that the user’s stress about a possible pregnancy would affect the veracity of the results. Multiple doctors argued that a woman, ‘may be under stress when she administers it’ so ‘[w]omen will have less to worry about if they let their doctors tell them whether they’re pregnant or not’ (Henderson, 1978: A10; McManus, 1978: A20). ‘People doing the testing will be befuddled, confused and nervous. Pregnancy testing is a very emotional thing and women can get so nervous that the test will have a very dubious end point’ (Henderson, 1978: A10). Joe Graedon (1979), a pharmacologist, wrote that the directions were ‘somewhat complicated’ and emotions may make use of the test challenging:

A woman who is distraught about the possibility of pregnancy (for example, a teenager unable to admit to the family doctor that she is sexually active) may find it difficult to concentrate on following the instructions exactly, and the test is not reusable. (p. B8)

Underlying these criticisms is the assumption that stress about a possible pregnancy would make a woman more likely to commit errors than a lab technician, neglecting the possibility that women may commit fewer errors because they strongly feel the gravity of the situation.

Many others, in addition to Mr. Graedon mentioned above, cited sexually active teens as the most problematic class. ⁶ Mary Alice Lee, a staff member at the Boston office of Planned Parenthood, believed that teenage girls, particularly keen on the ‘privacy factor’ of the test, might receive a false negative and be discouraged from seeking help (McManus, 1978: A20). Irene Wolcott, project director of the Washington-based Women and Health Roundtable, acknowledged both advantages and disadvantages of the tests:

The people most likely to utilize these tests are teen-agers who may be fearful of going to a physician, and these same people have the greatest need of counseling that goes along with tests done in clinics. Ads always show women thrilled at being pregnant, while the whole population out there may not be thrilled. (Krucoff, 1979: B5)

A Maryland physician, David Tobin, said that many users ‘are not the middle-aged, hopeful mothers-to-be portrayed in the commercials but rather they are single adolescents scared that they might be pregnant and fearful of the family doctor or local clinic’ (Powledge, 1980: E20). Dr Tulchinsky combined concerns about stress with those of gender and maturity, ‘What about that little girl who is scared and makes a mistake?’ (McManus, 1978: A20).

Indeed, ‘Laurel’ wrote to ‘Ask Beth’, a Boston Globe relationship advice column:

Can you tell if you are pregnant without going to the doctor? I’m too scared he’ll tell my mother. She’ll murder me, because she told me my boyfriend was too old (he’s 18, I’m 15) and would get me into trouble … How soon can a person be sure? (Ask Beth, 1980: H17)

In her response, ‘Beth’ directed ‘Laurel’ to several confidential and free clinics in her area before chiding her about lacking sexual maturity and responsibility. There was no mention of over-the-counter pregnancy tests in her response.

Doctors also cited the need for a user to be with another person during the process. Tom Crane, director of Los Angeles Family Planning Council, worried about the lack of counseling that was typically given when women were indeed pregnant (Elvenstar, 1979: OC_C1). Dr Isador Ances, an obstetrician and gynecologist at University Hospital in Baltimore, said, ‘Finding out you’re pregnant whether you’re going to end the pregnancy or continue it, is a momentous thing, and you shouldn’t be alone when it happens’ (Henderson, 1978: A10). As the technology moved away from a doctor’s office, there was, of course, the possibility that a woman would be accompanied by others who were not doctors.

Most medical professionals interviewed in newspapers also cited the cost of the test, which was often more costly than the inexpensive or free pregnancy tests available at many clinics (Henderson, 1978: A10; McManus, 1978: A20). Dr Ances of Baltimore stated, ‘I can’t understand why it would be convenient. All a woman is doing with this is wasting her money’ (Henderson, 1978: A10). A bill was even introduced in the Maryland legislature to require prescriptions for this ‘consumer ripoff’ (Valente, 1979: C2).

Members of the women’s health community were no less skeptical, but they also acknowledged more advantages to the tests. ‘A staff member at the Women’s Health Collective in Cambridge, who objected to the cost of the e.p.t., said that women who live in outlying areas where lab facilities are hard to come by, might find the home test useful’ (McManus, 1978: A20). Community health specialist Mina Bender, a nurse who ran two clinics in New York, said the tests are useful to ‘help de-mythify medicine by emphasizing self-responsibility … People should realize that they don’t have to be geniuses to know about medicine and how their bodies work’ (Krucoff, 1979: B5).

Though there were concerns and caution raised by the medical community, the ACOG and most individual doctors did not take a hardline position against the tests, which permitted a rhetorical waltz between doctors, health activists, the FDA, and the pharmaceutical companies:

The message is clear: Many physicians are prepared to cede a few of their responsibilities to patients. Many patients are determined to avoid doctors when they can. And many companies are delighted to take advantage of the situation. ‘What’s new is an interest on the part of the business community’, says Ken Hecht, director of scientific and technical relations … which markets a home pregnancy kit. (Powledge, 1980: E20)

Warner-Chilcott, the company that produced e.p.t., sought to refute specific claims as well as to assuage general fears of the unknown, both through their advertising to the public as well as through their media relations:

The Warner/Chilcott representative said e.p.t. instructions had been distributed to a thousand women who read them checking for clarity and comprehensiveness. He said he doubted even a teenaged girl would have difficulty understanding them. (McManus, 1978: A20)

Vice president of medical affairs for Warner-Chilcott, Arthur Flanagan, said that the test is beneficial for ‘the large segment of women who, for whatever reason, would like to do her own test and be knowledgeable of her condition first before she decides to share it’ (Krucoff, 1979: B5). He added, ‘But it is not a substitute for good medical care and for people who want the security of having a doctor perform the test’ (Krucoff, 1979: B5). Meanwhile, some advertisements stated that e.p.t. was a ‘private little revolution any woman can buy at her drugstore’ (Consumer Reports, 1978: 644). Warner-Chilcott deferred to, and thus attempted to make alliances with, two groups that were traditionally in a more adversarial relationship: women’s health advocates and doctors.

The business community quickly registered the potential market, though it came as somewhat of a surprise (Shannon, 1978: 1). Noting the growth of television ads, ‘the move reflects confidence in a product that has astounded industry and analysts with its market success’ (Brenner, 1979: D8). With three more tests soon to compete with e.p.t., analysts noted the inexpensive production costs leading to ‘nice profit margins’ (Brenner, 1979: D8). Though the women’s health community neither formally advocated the research nor the widespread distribution of the tests, at least one business writer posited a connection between profits and women’s health:

Sales of home pregnancy test kits doubled in the last year to reach $40…million, will double again this year ahead and, manufacturers claim, soar to $100 million by 1982. The ballpark figure for sales in the mid-80s: $500 million. The boom is part of the self-help revolution in women’s health, a crusade started by the women’s liberation movement and fanned by ‘Our Bodies, Our Selves’, the Boston Women’s Health Collective book. (McCormack, 1979: B2)

Interestingly, neither the 1976 nor the 1979 editions of Our Bodies, Ourselves includes any information about home pregnancy tests. It was not until the 1984 edition that the book advised women on when and how to take home tests (Boston Women’s Health Collective, 1976, 1979, 1984).

Still some wondered: ‘Women are buying them, but why?’ (Brenner, 1979: D8). Dr Elizabeth B. Connell, an obstetrics professor at Northwestern, uniquely positioned as a former official at the Rockefeller Foundation and Planned Parenthood and an advisor to the FDA, believed that privacy and being the first to know accounted for the boom:

There’s no question. They are on the same level of accuracy as those done in a laboratory or doctor’s office – when performed according to directions. It was first thought the kits would be used by frightened 13-year-olds. But now we know all kinds of women are using them – young, married, unmarried, divorced, diverse economic backgrounds. The concerns I have from a public health point of view is that once a woman knows she is pregnant she seeks medical care. (McCormack, 1979: B2)

Nearly every article about home pregnancy tests from the late 1970s advised women about seeking medical care from doctors. Under any circumstance that the test would come back positive, or if a woman suspected she was pregnant but the test result was negative, she was advised to report to the doctor immediately. Jane Brody (1978), the long-time health writer for The New York Times, detailed doctors’ still necessary roles:

If the woman is pregnant and wants to be, the doctor should examine her for potential complications and advise her about proper diet and avoidance of drugs, cigarettes, and alcohol. If she doesn’t want to be pregnant, she should seek an abortion right away, when the procedure is safest. Before doing the abortion, the doctor or clinic should repeat the pregnancy test. (p. C11)

So while some doctors questioned the test’s accuracy, many commentators thought that the test did not pose any threat to doctors’ professional position or ultimate authority in pregnancy testing or health management. The test merely displaced some ancillary tasks to women themselves that were typically conducted by technicians anyway. For this reason, some saw the home test as a redundancy and deemed the kits ‘largely unnecessary’ (Brenner, 1979: D8). Through this displacement of tasks, home pregnancy tests also created efficiencies. Women who received a negative test result, as well as their doctor, would be spared the time spent having an appointment that was unlikely to lead to further medical care. Women who received a positive test result would either make an appointment with their doctor, for prenatal care, or with an abortion provider.

As doctors debated the merits of the test, cultural prejudices about women and sex provided a backdrop to the debate. Despite the fact that women frequently received the same test in medical offices, women could be marked as promiscuous when they used the test at home. Consumer Reports (1978) (the leading American product review magazine) informed readers that, even if accurate, e.p.t. was needless, unless, of course, ‘she doesn’t want to be seen at the health department’ (p. 645). By connecting pregnancy tests to health departments, Consumer Reports called up the long history of health departments combating disease among the poorest and most marginalized people, particularly prostitutes. The message was clear: a woman’s pregnancy was least risky, both for her and for the public, when monitored by a medical professional.

Opportunities and foreclosures of regulatory lag

Meanwhile, the FDA had not yet issued its formal rules about home pregnancy tests, and e.p.t. was not subject to the agency’s approval (McManus, 1978). John Taylor, director of the FDA office in Boston, ‘said he’s received no comments or complaints in conjunction with e.p.t. since it was introduced in the area [three months earlier]’ (McManus, 1978: A20). As of early 1978, the agency was ‘currently formulating a policy on self-tests for pregnancy’, and though e.p.t. ‘does not now require premarket approval’, the FDA ‘expects to require assurance from the manufacturer that the test is highly accurate, safe and clearly labeled as to its proper use’ (Brody, 1978: C11). Some camps suspected that home pregnancy tests would ultimately be available by prescription (Kotulak, 1980: B2; Valente, 1979: C2).

Hampered in its jurisdiction by regulatory lag, the agency issued an informational article in its magazine ‘FDA Consumer’ (Eng [née Maio], personal communication; Maio, 1979). The article included historical information, general instructions, and the standard warnings about false positives and negatives, and parts of it were reprinted in some regional newspapers. The main message was clear: Go to the doctor!

Women who choose to use the pregnancy test kits at home should keep in mind the fact that this is only a preliminary test. In all circumstances, follow up a positive reading with an immediate visit to a doctor. And, a woman should also consult her physician if symptoms of a pregnancy continue after a negative reading. (New Pittsburgh Courier, 1980: 14)

In other media outlets, FDA press officer Jacqueline Maio stated that ‘the at-home test is only a method of making a preliminary diagnosis, instructions must be followed strictly and false readings may create or disguise other medical problems’ (Krucoff, 1979: B5). ‘While an at-home pregnancy test can give an accurate diagnosis, consultation with a doctor is essential to assure proper medical care’, Maio explained (Krucoff, 1979: B5). It was a ‘cautious period’ at the FDA, because the agency was dealing with a ‘new innovation’, but they ‘[didn’t] want to step on the doctors’ toes’ (Eng [née Maio], personal communication).

By the time that the FDA was able to classify them in one of the three new risk categories of devices, the pregnancy tests were already widespread in the US market. Arguably, home pregnancy tests belonged under Class I, low-risk devices. They had no major role in life or health and presented no major risks of illness or injury – certainly no more than other Class I devices like scalpels, eyeglasses, and thermometers. The internal FDA debate, however, was whether home pregnancy tests would be in Class II or III, moderate or high-risk devices, respectively (Suzanne Junod, 21 October 2011, personal communication). For each device, a panel of ‘experts’, including lawyers and doctors, would hold both open and closed sessions to ‘receive information from interested parties, principally manufacturers and industry groups’ (Boguslaski, 1985). Though these panels undoubtedly received information and lobbying from manufacturers, it is unknown which companies were present and what they argued. ⁷ Undoubtedly, they argued for a lower classification and less regulation. The classification panel would then conduct a risk-based assessment by answering a series of questions, produce a ‘classification sheet’ for each device, and provide a recommended class (I, II, or III) to the Bureau of Medical Devices for codification. Finally, a junior FDA attorney would be assigned to write the classification language for each device.

Even though Warner-Chilcott did not mass market e.p.t. until 1978, their early test market had a tremendous impact on the future of home pregnancy tests. Three other devices used e.p.t.’s grandfathered status, arguing that their devices were substantially equivalent: Answer (Diagnostic Testing/Carter-Wallace, Inc.), Acu-Test (J. B. Williams, Inc./Nabisco), and Predictor (Whitehall Laboratories/American Home Products, Inc.) (Family Planning Perspectives, 1979). ⁸

Following the classification process, in 1979 e.p.t. was placed in Class II (Eng [née Maio], personal communication; Family Planning Perspectives, 1979; Maio, 1979). Attorneys drafted language specific to pregnancy tests to include in Section 510(k) of the MDA regulations to smooth the process for future devices.

Nearly forty years later, home pregnancy tests that use urine to measure a user’s level of hCG still get 510(k) clearance, through arguments that they are substantially equivalent to devices already on the market. As of 2015, over 200 home pregnancy tests had been brought to market using this process. Despite the vast technological changes that have occurred since 1976, from the early hemagglutination in test tubes to the digital, plastic-enclosed, ultra-filtration sandwich assays to be placed in the urine stream commonly used today, the definition of substantial equivalence allows for leeway in the development of these diagnostic products.

‘Substantial equivalence’ is a legal device that has costs and benefits to be weighed by device manufacturers. The advantages of this approach are evident – it reduces costs of Class III reviews. Approximately 3,000 devices are cleared through the 510(k) process each year, taking as little as ninety days, while only about forty are approved through premarket approval, which can take up to a year and a half. On the other hand, seeking ‘substantial equivalence’ might limit precisely what a device is able to do in terms of its use. For instance, though more advanced technology exists, home pregnancy tests remain binary; that is, they only respond with a positive or negative measurement of the presence of hCG in the urine. ⁹ The tests available over-the-counter do not yet respond with a ‘quantitation’ of hCG (Food and Drug Administration (FDA), 2000) like those available at a doctor’s office. A quantitative sample can indicate the healthy or unhealthy progression of a pregnancy, an ectopic pregnancy, or a possible miscarriage. It is unclear whether such devices could be seen as having a different underlying ‘use’ than the predicate device.

The advantage of a substantial equivalence approach for the FDA is that the agency is still able to regulate products as technological changes happen and devices are improved. If ‘substantial equivalence’ were limited in definition to clause (A) (i) ‘same technological characteristics’, the FDA would be unable to regulate a vast array of products on the market. Instead, devices may, and often do, have ‘different technological characteristics’ when they are updated or improved upon. The limitation of this provision, however, is that a product must be a ‘device’, must be for the same ‘use’, and must have the same considerations for ‘safety and effectiveness’ as the predicate device. ¹⁰ There are vast technological differences between early home pregnancy tests and those that are used today, but given that they are for the same use and have the same safety considerations, substantial equivalence and the 510k process have permitted incremental changes to occur with light regulatory supervision.

Regulation, in the case of home pregnancy tests, was not a mere control on innovation or diffusion. Rather, the sequence of judicial decisions from Bacto-Unidisk to OvaII, the design of the MDA, the intermediate classification of the device, and the somewhat flexible role of ‘substantial equivalence’, all provided an opportunity for juris-technical accordance and facilitated the trajectory of the technology into the hands of laypeople.

Conclusion

When the home pregnancy test was introduced to a large American audience in 1978, the social terrain was almost entirely ripe. The test fit perfectly into the framework of self-knowledge, individual choice and individual responsibility that the women’s health movement had developed and promoted. There were risks of home pregnancy testing – a user misdiagnosing whether she was pregnant or not, and the psychological burden of being alone while receiving monumental news – but due to a favorable court decision and regulatory lag, the various groups were able to align themselves into one general party line: It isn’t that risky.

When particularly innovative technologies make great leaps forward, regulatory delays can provide an opportunity for industrial interests to secure market share unhindered (Nelson and Robinson, 2014). In the case of the juris-technical accordance of the home pregnancy test, there were at least three different regulatory delays, each which functioned somewhat differently. First, before the court decision in OvaII, pregnancy tests were barely noticeable in the US market. It is unclear, and perhaps unknowable, why Faraday decided not to market the test widely, but it is known that the regulatory framework was unsettled and going to market was a financial risk. Next, following the decision in OvaII, companies were able to market the test confidently and without fear of regulatory reprisal in a ‘technological free-for all’, and they did test marketing with particular urgency, given the coming regulatory schema. Nevertheless, it was not until the passage of the MDA several years later that Warner-Chilcott, a large pharmaceutical company, decided to market widely and advertise their test e.p.t.. It was at that time that the home pregnancy test received widespread public attention and acceptance. Thus the pregnancy test was in the home, and the challenge for regulators was to find a way to accommodate that.

Moreover, when the classification schema was ultimately enacted, the interested social groups were able to align themselves strategically. For example, large pharmaceutical interests intentionally used the language of the women’s health movement while marketing within and to a white and heteronormative marital model to ease the device’s mainstream acceptance. Though the various actors with heterogeneous long-term interests coalesced around a common understanding of the device, power exists in patterns of value judgments, and thus it is important to remain attuned to which groups use ‘rights language’ and for what purpose.

Medical professionals raised the most concerns about the device’s place in American social life. Like later medical technologies that have moved from hospital to home, the home pregnancy test challenged and blurred the jurisdictional boundaries of technicians, doctors, and patients (Conrad, 1992: 226; Oudshoorn, 2011: 69–70). In the case of medical technicians, the entire profession may have been threatened because their expertise and networks had not been diversified; some, whose main business was pregnancy testing, could be entirely replaced by the new test. The case of technicians appears to be a pure case of a jurisdictional conflict in which a monopoly was being divested of its power (Abbott, 1988). While the home pregnancy test marked one battle of an ongoing jurisdictional conflict of the medical profession against self-care, what some have called laicization (Abbott, 1988), the test also marked a reconfiguration and diffusion of medical power (Eyal, 2013). Medical doctors, unlike technicians, would remain gatekeepers for the cases that they most wanted to see. Women happy to find they were not pregnant would need no medical care, and women seeking obstetric care, abortions, or fertility services would filter to the appropriate providers. The ancillary rules and tasks of surveilling bodies and maintaining health would simply be rendered less visible and extended in an ‘expertise expansion’ to patients themselves (Armstrong, 1998; Childerhose and MacDonald, 2013; Epstein, 1995; Murphy, 2013). Brought on by self-diagnosis and the movement to optimization, doctors and patients were rendered partners in the reproductive endeavor.

To explain the trajectory of the pregnancy test out of medical offices and its assimilation into homes, this study shows the necessity of studying the multiple controversies the test encountered. Without delving in detail into Bacto-Unidisk, OvaII, and the Medical Device Amendments, the rich case law and statutory law of home pregnancy testing might be analytically reduced to a control on technological innovation and progress. This case suggests that the settlement of the home pregnancy test was facilitated by the process of juris-technical accordance in which the laws and legal processes were influenced by shifting professional boundaries and changing views of medical expertise. Indeed, though the regulatory lag permitted this to start, the regulation ultimately translated various interests so that disparate networks could align. Moreover, this case shows that by taking a co-productionist approach to regulatory science, STS scholars can bring a unique analytic view to a field that has remained largely self-contained and introspective. Particularly in the burgeoning field of self-monitoring technologies, STS can contribute a richer understanding than legal analysis alone can provide.