Public Health Effectiveness of the FDA 510(k) Clearance Process Balancing Patient Safety and Innovation: Workshop Report (2010) / Chapter Skim
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2 Legislative History of the Medical Device Amendments of 1976
2 Legislative History of the Medical Device Amendments of 1976
Pages 3-6
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From page 3... ...
There were three precedents to consider in drafting of the 1976 amendments, Hutt said. The Food Additive Amendments of 1958 stated that all food additives on the market on the date of enactment had 3 years, until 1961, to obtain FDA approval.
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From page 4... ...
The Supreme Court decision stated that FDA did not have adequate device legislation and so the Court was expanding the concept of a drug so that the agency could require new drug applications for diagnostic products and other important medical items. That meant either that FDA was going to go forward and designate whatever devices it deemed necessary as drugs or that Congress needed to approve new device legislation.
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From page 5... ...
The initial House bills of 1970 and 1971 defined class I as everything that was GRAS and GRAE. The use of GRAS and GRAE were of concern because as a result of their inclusion in the 1958 Food Additive Amendments and the 1962 Drug Amendments, companies went ahead and marketed their products as safe and effective, and then FDA would have to bring legal action in the courts to take them off the market.
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From page 6... ...
(In response to a committee question, Hutt added that although it was not feasible then, it would be realistic now to set up a broad national system that would link databases of institutions that use medical devices.) The drafters' intent was that FDA would actively set priorities and potentially revise what was considered a reasonable model for substantial equivalence as it went along rather than necessarily becoming passive and allowing things to continue with no end in sight.
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