Proposed Changes to 21 CFR 820

by Michael B. Checketts published on June 14, 2022

The FDA regulatory requirement 21 CFR 820 for medical device Current Good Manufacturing Practice (CGMP) for Quality System Regulations (QSR) is undergoing a significant revision. The purpose of this webinar is to familiarize medical device manufacturers (marketing or intending to market in the USA), with the proposed changes coming “around the bend”. Though the standard has been around a very long time (since 21 Jul 1978), the FDA is proposing to amend this regulation to align more closely with the international consensus standard for devices by converging with the Quality Management System (QMS) requirements used by other regulatory authorities from other countries. They are therefore (by reference) incorporating the international standard ISO 13485:2016 into CFR 820. This action, when finalized, is expected to align the regulatory framework for the USA with that used by other global regulatory authorities to promote consistency in the regulation of devices and provide a timelier introduction of safe, effective, high-quality devices for patients. Join us for this quick look “behind the scenes” and participate in a discussion on the forthcoming changes and how they may, or may not impact the way you are presently doing business.