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2023•BMJ Surgery Interventions & Health TechnologiesOpen access

Medical device risk (re)classification: lessons from the FDA’s 515 Program Initiative

Maryam Mooghali, Vinay K. Rathi, Kushal T. Kadakia, Joseph S. Ross, Sanket S. Dhruva

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Abstract

#### Key messages box The 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act granted the US Food and Drug Administration (FDA) regulatory authority over medical devices. Congress intended for FDA’s review requirements to correspond to the amount of information needed to provide ‘

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#### Key messages box The 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act granted the US Food and Drug Administration (FDA) regulatory authority over medical devices. Congress intended for FDA’s review requirements to correspond to the amount of information needed to provide ‘

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OpenAlex reports 10 citations for this work. Citation counts describe recorded attention and do not establish research quality.

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Available abstract

#### Key messages box The 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act granted the US Food and Drug Administration (FDA) regulatory authority over medical devices. Congress intended for FDA’s review requirements to correspond to the amount of information needed to provide ‘

Key concepts: Food and drug administration, Medical device, Key (lock), Business, Medicine, Internet privacy, Political science, Computer security

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