FDA officially, published in the Federal Register on February 2, 2024, the new Quality Management System Regulation (QMSR) which is the first revision of 21 CFR 820 since 1996. FDA has incorporated ISO 13485:2016 into the regulation by reference and has additional U.S. country specific requirements. In addition, the Federal Register contained the concurrent amendment to Combination Product GMP requirements in 21 CFR Part 4. Hear first-hand from the 1996 QS regulation author and ISO 13485 International TC 210 QMS expert on how these changes will affect medical device manufacturers from the requirements to the comments in the Preamble, to FDA medical device inspections, and more…
- Understand the “Nuts and Bolts” of this new FDA revisions to 21 CFR Part 820 and 21 CFR Part 4
- Learn the specifics of the U.S. country specific requirements “By The Numbers”
- Plan for the “Increase in Regulators Expectations”
- Be aware of the “Possible Surprises – Combination Products”