Hill Leadership: Support Science-Based Assessments by FDA
Contact: Karen Batra, +1-202-449-6382 or kbatra@bio.org

New report urges overhaul of medical device approvals
The Institute of Medicine says the FDA's current approach doesn't meet its goals.

FDA Issues New Guidance for 510(K) Medical Device Approvals
The U.S. Food and Drug Administration (FDA) just issued new draft guidance for 510(K) device approvals. The draft guidance clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission. Congress gave the FDA authority over medical devices in 1976 and allowed it a quick review process for new devices it [...]