FDA Announces Its Plan for Encouraging Reliance on Newer Predicate Devices and Medical Device Performance Criteria

On November 26, 2018, the Food & Drug Administration (FDA) announced its intent “to modernize the FDA’s 510(k) clearance pathway”1 by encouraging manufacturers to rely on newer (that is, 10 years old or less) medical devices as predicate devices in 510(k) notifications, and providing an alternative 510(k) pathway that allows manufacturers to rely on objective safety and performance criteria, at least for certain well-known devices. This revised approach comes at a time when advances in technology are rapidly outpacing FDA’s ability to review and clear new medical device technology for market. FDA has also come under increasing criticism in recent years for failing to detect problems in certain medical devices, which have, in some instances, caused injuries to consumers. FDA believes that this new approach will improve medical devices’ safety and performance, and expects hope that this new pathway will become the norm for approval of medical…

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