The FDA published the Quality System Management Final Rule on January 31st. This rule amends the current device good manufacturing practice requirements of the Quality System regulation (21 CFR Part 820) to incorporate ISO 13485: 2016-Medical Devices-Quality Management Systems.
Why is this change significant?
By doing this, the FDA has harmonized their regulatory framework with that of other global regulatory authorities. It is important to note that device manufacturers have until February 2nd, 2026 to comply with the QS regulation.
If you have any questions, or need help in your transition to the new QS regulation, please contact us. Our regulatory experts are ready to help you comply.