What Medical Device Manufacturers Stand to Gain From Part 820/ISO 13485 Harmonization

The U.S. Food and Drug Administration (FDA) has long been largely in favor of medical device manufacturers producing safe and effective devices. So much so that in 1996, the agency put this assertion into writing with its 21 CFR Part 820 (aka the Quality System Regulation (QSR)). In a nutshell, the QSR applies to the methods, facilities, and controls for designing, manufacturing, packaging, labeling, storing, installing, and servicing devices intended for human use.

It’s evident that a lot has changed across the regulatory landscape and the medical device industry since then — that is, except for 21 CFR Part 820 itself. In other words, “The FDA has not undertaken a significant revision of Part 820 since the 1996 Final Rule.” Essentially, the FDA cited that Part 820 has been an effective regulation, providing assurance that devices are safe and effective and compliant with the Food, Drug, and Cosmetic (FDC) Act.¹

Quality Regulations Go Global

Meanwhile, the International Organization for Standardization (ISO) developed the standard, ISO 13485, which also applies to a company’s quality system. The main differences between the regulation and the standard are that ISO 13485 is used internationally by many regulatory agencies, and it has been updated a number of times since its inception, also in 1996.²

For some time, the FDA has agreed that ISO 13485 checks all the boxes for quality system regulation. That said, since around 2018, the agency has been busily working on leveraging the guidelines in the standard by harmonizing 21 CFR Part 820 with the 2016 version of ISO 13485 — and it’s finally coming to fruition. The resulting regulation will be referred to as the Quality Management System Regulation (QMSR). Medical device manufacturers have cause to celebrate for a few reasons because the FDA QMSR will:

• Eliminate the redundancy of having to comply with two different, but substantially similar, requirements to sell devices globally.
• Promote more consistency among FDA and global regulatory agencies in medical device regulation.
• Alleviate the confusion in the event ISO 13485-certified companies get called out by FDA inspectors for lacking terminology or elements required by the QSR.
• Put regulations more in line with current medical device manufacturing technologies and processes.³

FDA QMSR: A Notable Regulatory Precedent

The FDA QMSR was partly inspired by the Medical Device Single Audit Program (MDSAP) that went into full implementation in 2016. This program allows a recognized auditing organization to conduct a single regulatory audit of a medical device manufacturer’s quality management system (QMS) that satisfies the requirements of multiple regulatory authorities participating in the program. Similar to MDSAP, the harmonization of 21 CFR Part 820 and ISO 13485 will help medical device companies more easily facilitate access to international markets by simplifying compliance with diverse regulatory frameworks.

To find out more about the FDA ISO harmonization, read the Q&A: “How to Get Ready for 21 CFR Part 820/ISO 13485 Harmonization.” Learn how you can make the transition fast and seamless with MasterControl quality management software solutions.

References

1. “Medical Devices; Quality System Regulation Amendments,” U.S. Food and Drug Administration (FDA), Proposed Rule, Federal Register, Feb. 23, 2022.
2. Supra note 1.
3. “FDA Proposes to Harmonize the Quality System Regulation With ISO 13485,” McKenzie E. Cato & Anne K. Walsh, et al, FDA Law Blog, March 7, 2022.