Heads Up Medical Device (and Cosmetic Device) Manufacturers and Importers!

On January 31, 2024, FDA issued a final rule, which will amend medical device current good manufacturing practice (cGMP) requirements of the Quality System (QS) Regulation under 21 CFR Part 820, to more closely align with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the globe.

Seeking to modernize and harmonize the regulations with the international consensus standard for devices, the new regulation is intended to converge the quality management system (QMS) requirements used by other regulatory authorities from other countries by incorporating by reference an international standard (ISO 13485:2016) specific for device quality management systems.

The rule amends the regulation title (the revised part 820 is referred to as the Quality Management System Regulation, or QMSR), and establishes additional requirements that clarify certain expectations and concepts used in ISO 13485. The FDA has also made confirming edits to 21 CFR Part 4 to clarify the device Quality Management System (QMS) requirements for combination products.

FDA anticipates that this action will continue the Agency’s efforts to promote consistency in the regulation of devices and to provide timelier introduction of safe, effective, and high-quality devices for patients. In terms of timeline, FDA is providing device manufacturers and importers two (2) years to modify their Quality Systems to meet the requirements of the QMSR rule by February 2, 2026. Until then, manufacturers are required to comply with the existing Quality System Regulation.

On the regulation roll-out front, the Agency anticipates that the greatest impact will likely be on training FDA staff responsible for assessing compliance with medical device quality management system requirements and updating information technology systems. The FDA plans to address this via internal trainings to familiarize staff with the new regulation and any updates to procedures, processes and policies.

Importantly for device manufacturers and importers, the FDA will also develop a new inspection process to align with the requirements of the new QMSR; this process will be developed for implementation when the rule takes effect, which is again is two (2) years from publication. The FDA will begin to enforce the QMSR requirements upon the effective date, February 2, 2026.

We recommend medical device manufacturers and importers, including cosmetic devices, ensure compliance with the existing Quality System Regulation, and begin to familiarize themselves with ISO 13485. This includes conducting a mock FDA GMP audit and gap assessment. We also recommend businesses monitor FDA’s updates and issuance of guidance documents as the Agency updates procedures and policies in the next 2 years. We will continue to monitor and advise on these developments.

For questions on medical device compliance, including submission of 510(k)s, QMS/GMP compliance, FDA inspection preparedness, and enforcement matters, please contact us at info@garg-law.com.