The wait is finally over! On January 31, 2024 FDA issued the Quality Management System Regulation final rule. "The FDA is amending the title of the regulation, and establishing requirements and provisions that clarify certain expectations and concepts used in ISO 13485:2016. The revised part 820 is referred to as the Quality Management System Regulation (QMSR)."
FDA Amends 21 CFR 820
FDA announced some time ago that it planned to align 21 CFR 820 more closely with ISO 13485:2016. Now that final rule has been issued, this changes the title of the regulation and establishes additional requirements that FDA states will clarify certain expectations and certain concepts used in ISO 13485.
The effective date for compliance is two years after publication in the Federal Register. FDA states that it will begin to enforce the QMSR requirements upon the effective date which is February 2, 2026. What's important to understand is that this does not mean that you must become ISO 13485 registered. It simply means that your documentation must follow the requirements under ISO 13485:2016.
SafeLink Consulting is ready to assist clients in transitioning their Quality Management System (QMS) to these new requirements. Whether you currently use the Cloud-based UQ System or manage your QMS manually, our team is here to support you. For clients subscribing to the Grand Avenue Software. rest assured that you will already be utilizing the ISO 13485 format, but we will work with you to ensure any necessary updates are made.
Wondering what steps you need to take before February 2, 2026?
Look no further, because SafeLink Consulting is here to help you navigate the new FDA regulations. Contact us today to learn how we can assist you in meeting this final rule of quality system regulation. Discover more about dental and medical device QMS software.
And while you're at it, take a moment to explore some other important topics, such as enhancing FDA Quality Compliance with an eQMS, the rise of FDA Inspection for dental labs, and 7 steps to successfully navigating FDA renewal registration. Stay on top of FDA Dental Regulation and let SafeLink Consulting guide you every step of the way.
SafeLink Consulting can assist your business with developing a Quality System and Good Manufacturing Practices - GMP for medical devices manufacturers including the dental lab, workplace health & safety training, infection control training and HIPAA training online, plus more.
