After four years in the works, the U.S. Food and Drug Administration (FDA) has finally published their much-anticipated proposed rule (PR) to amend the Quality System Regulation (QSR) (21 CFR Part 820) on 2/23/2022. This proposed rule not only impacts U.S. manufacturers but all manufacturers with product in the U.S. market.

Take a deep dive into this much-anticipated proposed rule (PR) by attending “ASK THE EXPERT: The implications of U.S. FDA’s harmonization of the Quality System Regulation with ISO 13485”. Filled with valuable information, this event will take place on May 5th starting at 2:15 pm, Room 131+132, MedTech Forum 2022, Barcelona International Convention Center, Plaça de Willy Brandt, Barcelona, Spain.

FDA asserts that the amendment to the QSR will result in bringing new medical devices to the market more quickly and reduce the burden on medical device providers by creating a single quality system structure for those already adhering to both ISO 13485 and Part 820.

The PR plans to adopt ISO 13485 by reference. FDA provides a table in the PR indicating where it believes that ISO and the current requirements under Part 820 are substantially similar. The proposal includes maintaining some aspects of 820 and ISO, obsoletion, addition, clarification, and revision.

“Expert” Ricki A. Chase, M.S., Vice President, Lachman Consultant Services, Inc. will provide timely advice and lead the discussion, which will include an understanding of the nuances of the PR, how the final rule will and will not change FDA’s inspection activities and programs, and highlight how manufacturers in the U.S. market already will need to adjust should the PR be made final. This is also a great opportunity for those who are not in the U.S. market but plan to enter to understand the current mindset of FDA in medical device regulation.

Register here: