This guidance is intended to provide recommendations for collecting a representative sample for testing when fish and fishery products are subject to detention without physical examination (DWPE) due to the appearance of adulteration caused by pathogens.
This document provides recommendations for premarket submissions for orthopedic devices that contain metallic and/or calcium phosphate coatings on the surface.
This draft guidance provides FDA’s current thinking on the 510(k) Third Party Review Program and review of EUA requests by third party review organizations.