The 1976 Medical Device Amendments to the federal Food, Drug, and Cosmetic Act do not apply to devices marketed before the law was passed.

Question

Quizplus · Accepted Answer

The 1976 Medical Device Amendments include provisions for devices marketed before the law was passed, categorizing them as "pre-amendment devices" and subjecting them to FDA review and regulation to ensure their safety and effectiveness.

The 1976 Medical Device Amendments to the Federal Food, Drug