Downclassified Porcine Wound Dressings Would Still Need 510(k)s - Panel
This article was originally published in The Gray Sheet
Executive Summary
Porcine derived wound dressings would still need to be subject to 510(k) premarket notification clearance despite downclassification of the devices to Class I, members of FDA's General and Plastic Surgery Devices Panel recommended at a Nov. 17 meeting in Rockville, Maryland.