THIRD-PARTY INSPECTIONS COULD ELIMINATE SUBMISSION OF 510(k)s FOR SOME DESIGN CHANGES, FDA's JOHNSON SUGGESTS; "ONE-STOP SHOPPING" AUDITS POSSIBLE
This article was originally published in The Gray Sheet
Executive Summary
Third-party verification of manufacturers' compliance with FDA's quality systems regulation could eliminate the need for 510(k) clearance for at least some design changes, Ronald Johnson, director of FDA's Pacific Region office, said June 24 at a Food and Drug Law Institute meeting in Washington, D.C. Johnson made the suggestion as a possible incentive for industry to participate in a voluntary third-party inspection program.