Three U.S. Senators recently introduced legislation that would alter the U.S. Food and Drug Administration's post-market surveillance of medical devices.
Sens. Chuck Grassley, R-Iowa, Richard Blumenthal, D-Conn., and Herb Kohl, D-Wis. introduced the The Medical Device Patient Safety Act, S. 1995. Currently, the FDA can approve new moderate-risk medical devices through the 510(k) process if the product is found to be as safe and effective as a substantially similar medical device already on the market. Though the agency can request clinical study data on proposed new devices under the 501(k) process, it is still viewed as a fast-track approval process, compared to the premarket approval process for new products in the high-risk device category.
The bill would give the FDA the authority require companies to submit post-market data as a condition for gaining approval for moderate-risk medical devices under the fast-track process. The FDA could also order companies to conduct additional safety studies of devices after they are approved, and could grant conditional approvals pending the result of any ongoing trials. The proposed legislation would also require the FDA to assess recalls to determine whether they were implemented effectively.
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