Two regulatory pathways for devices were also established: premarket approval (PMA) and premarket notification, known as the 510(k) pathway. 15 These amendments assigned ultimate regulatory authority for devices to the FDA established a 3-category, risk-based classification system for devices (I, II, III) and required postmarket adverse events reporting. Quiz Ref ID The importance of pre- and postmarket device regulation and the dangers of decentralized regulatory authority were illuminated by the Dalkon Shield, leading to the passage of the Medical Device Amendments of 1976. 13 Despite reports of significant morbidity and mortality associated with use of the device, removal of the Dalkon Shield from the market was slow voluntary recall was not issued until late May of 1974, months after the manufacturer became aware of hazards. 12 Furthermore, women who became pregnant were at higher risk for complications, including septic pregnancy and maternal death. 10, 11 Postmarket research revealed a 4.7% pregnancy rate and a 6.3% rate of device expulsion (ie, displacement from its proper uterine position) in Dalkon Shield users-far higher than the rates touted by the manufacturer. 9 Due to limitations in regulatory requirements at that time, no federal oversight of the device's premarket assessment occurred. 8 Its use skyrocketed, with approximately 2.2 million devices implanted in American women by 1974. The Federal Food, Drug, and Cosmetic Act of 1938 authorized product oversight by the FDA, 4 but even with amendments 5 in 1962 inspired by the tragic health consequences of sulfanilamide 6 and thalidomide, 7 the FDA did not regulate devices until 1976, when complications associated with the Dalkon Shield spurred new legislation.Ī contraceptive device inserted into a woman's uterus for pregnancy prevention, the Dalkon Shield was marketed to American women beginning in 1971 as a better alternative to contraceptive pills. 2 As a result, the Pure Food and Drug Act was signed into law in 1906, 3 creating a federal entity that would become the FDA.
1 Medical product oversight began with a focus on food and medications during the early 20th century, spurred by public concern about the danger posed by common food additives, such as formaldehyde. In 2018, the US Food and Drug Administration (FDA) approved more than 100 novel devices, a number that surpassed the prior year's record and represented a fourfold increase over 2009. The dramatic expansion of device use in health care demands that clinicians understand device regulation and its strengths and weaknesses as a key ethical and clinical responsibility.