Historically, the FDA has had its own regulation (21 CFR Part 820) to regulate the quality systems of medical device manufacturers. This regulation establishes the requirements for good manufacturing practices (CGMP), which govern the methods, the facilities and controls used for the design, manufacture, packaging, labeling, storage, installation and servicing of all finished devices intended for human use, these requirements are aimed at ensuring that finished devices are safe and effective and that they comply with the Federal Law on Food, Drugs and Cosmetics.
These requirements have been very similar to those requested by international regulations on quality management systems, but the FDA had not adopted them until now.
The agency has published a proposed rule that would amend the 21 CFR Part 820 regulation to reference the international standard ISO 13485:2016 and harmonize its requirements, as they have determined that the requirements of ISO 13485 are, when taken in their substantially similar to the current part 820 requirements, providing a similar level of assurance in a company's quality management system and the ability to consistently manufacture devices that are safe, effective, and compliant FD&C.
Although the proposed regulation will harmonize the requirements of ISO 13485:2016 as the basic quality management system requirements, there will be additional FDA-specific requirements created to ensure consistency and alignment between ISO 13485 and existing requirements. in the FD&C Act and its implementing regulations. This new regulation will be called Quality Management System Regulation (QMSR).
FDA proposes that any final rule based on this proposal become effective 1 year after the date of publication of the final rule in the Federal Register. This approach is intended to provide adequate time for manufacturers to make the necessary changes to meet the requirements of ISO 13485. We welcome any feedback on this approach.
Although this rule does not affect FDA's authority to conduct inspections under section 704 of the FD&C Act, FDA intends to replace its current inspection approach for medical devices, the Quality System Inspection Technique ( QSIT), with an inspection approach that will be consistent with the requirements of part 820 proposed as finalized.
Note: FDA inspections will not result in the issuance of certificates in accordance with ISO 13485, nor is FDA developing a certification program for ISO 13485. In addition, manufacturers with a certificate of compliance with ISO 13485 are not exempt from FDA inspections.