Stephane Bandeira

A proposed FDA regulation has been published, requesting public comments, to modify the existing requirements of the Quality System (QS) regulation (21 CFR Part 820) for medical device quality management to incorporate the international standard AND address the needs of medical devices manufacturers. The proposed regulation, if approved, would help to harmonize the U.S. requirements for QMS with the requirements of the International Organization for Standardization (ISO).

This is to ensure that the device will be safe for use by the public.

The FDA and the medical device industry have been collaborating for decades to ensure that devices are safe for public use by implementing a quality system regulation. The Food and Drug Administration has also established a Medical Device Good Manufacturing Practices (GMP) in order to regulate the manufacturing, testing, labeling, packaging, and distribution of medical devices. This is done to ensure patients' safety by monitoring the production of highly regulated medical devices.

The Medical Device Safety Action Plan was put into place to reduce the risks of medical devices and improve patient safety by implementing GMP regulations. Some of the key initiatives in this plan are:

• Establishing an international framework for regulating medical devices

• Improving how we monitor post-market surveillance

• Strengthening our oversight of high-risk device manufacturers

• Improving how we assess the safety and effectiveness of new technologies

While the current QS regulation provides sufficient and effective requirements for establishing and maintaining a quality management system, regulatory expectations have evolved since the regulation was implemented over 20 years ago. By aligning to ISO 13485:2016, FDA believes that device quality management systems will be better integrated with international regulatory expectations.

The proposed rule will be open for public comments for 90 days at www.Regulations.gov under docket number (FDA-2021-N-0507).

To understand more, check the FDA's announcement here and here.