FDA 510(k) RESCISSION POLICY WILL BE CHALLENGED BY HIMA
This article was originally published in The Gray Sheet
Executive Summary
FDA 510(k) RESCISSION POLICY WILL BE CHALLENGED BY HIMA in a petition under development, the Health Industry Manufacturers Association says in an "Action Plan on FDA Compliance and Enforcement" released the week of Aug. 1. The citizen's petition, which has already been drafted, is under review by HIMA committees including its enforcement and product approval task forces.