The original FDA statute, the Pure Food and Drug Act of 1906, did not cover medical devices. When Congress replaced it with the Federal Food, Drug, and Cosmetic Act of 1938 (FFDCA), it extended the law to medical devices, but for all intents and purposes devices were treated as drugs, and the definitions of the two categories overlapped. The overlap enabled the FDA, after a change in the drug law in 1962, to impose rigorous premarket approval of some products that today would be deemed devices.
In the 1960s, Presidents Kennedy, Johnson, and Nixon all called for new regulatory legislation specific to medical devices. By the early 1970s, several high-profile public-health problems with medical devices had led to political momentum for a device statute.2
The Medical Device Amendments of 1976 established an elaborate and detailed scheme, more than doubling the length of the FFDCA.3 After differentiating drugs from devices, the law created a broad array of authorities for the FDA to regulate devices after they had entered the marketplace. Moreover, in contrast with the US drug laws of the time, Congress limited premarket approval to only a small universe of devices. Where the drug law generally treated all drugs alike, the new device amendments created three categories of devices that were based on the risks presented and the ability of postmarketing controls to manage them. Only the highest-risk category would require agency review and approval as a precondition for commercial sale and routine medical use. The other two categories would be subject not to a rigorous review but merely to a requirement that the manufacturer of a device in one of the categories notify the FDA, at least 90 days before commencing marketing, of its intent to distribute the product commercially. That requirement was set forth in Section 510(k) of the FFDCA and thus is called a 510(k) notification.
The new law directed the FDA to categorize the device types in the universe of devices on the market when the 1976 law was enacted (so-called preamendment devices) into three categories—called Class I, Class II, and Class III—on the basis of the definitions that Congress adopted. Thereafter, under the statute, a device type could be transferred from one class to another on the basis of new information showing that it would now be more appropriately assigned to a different class. The criteria for the three classes were stated in the 1976 law as follows:
2H.R. REP. No. 94-853, at 8 (1976).
3Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539 (1976) (hereinafter MDA).