FDA 510(k) Risk-Benefit Guide Oversteps Regulatory Bounds, Attorney Says

FDA 510(k) Risk-Benefit Guide Oversteps Regulatory Bounds, Attorney Says-insidehealthpolicy: A device industry attorney says FDA may have overstepped its legal bounds with a new guidance document that she suggests applies the same benefit and risk standards for innovative devices to 510(k)s with technological differences from their predicates. The attorney, who previously worked for FDA's device center, says the policy is a fundamental reworking of the 510(k) review process, and questions if the agency had quietly implemented the policy prior to issuing the draft guidance. The guidance, however, says it neither changes the 510(k) premarket review standard nor requires more performance data from submitters of a 510(k).