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On Wednesday, 8 June 2016, a bill was introduced in Congress that would, if passed, amend the Federal Food, Drug, and Cosmetic Act to require physicians and physicians’ offices to submit reports to FDA on hazards relating to medical devices. The rationale behind the proposed amendment is to give the FDA earlier notice of risks associated with medical devices used in the United States. HR 5404 comes in response to a delay in reporting of potential risks associated with the use of laparoscopic power morcellators, but it has implications for the entire medical device industry.

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