FEWER 510(K)s FOR DEVICE DESIGN CHANGE WILL BE NEEDED UNDER GMP REVISIONS, FDA'S HOOTEN SAYS; FINAL REGULATION WILL ALLOW USE OF ELECTRONIC SIGNATURES
This article was originally published in The Gray Sheet
Executive Summary
Fewer submissions of 510(k)s for design modifications could result from the proposed addition of design controls to device good manufacturing practices regulations, Fred Hooten, acting director of the Division of Enforcement III in the device center's Office of Compliance, said at a May 24 meeting of the Association for the Advancement of Medical Instrumentation in Washington, D.C.