FDA’s Proposed Global Regulatory Harmonization for Medical Devices

Charlene Echeverria Burciaga 

Associate Editor

Loyola University Chicago School of Law, J.D. 2023

On February 23, 2022, the Food and Drug Administration (FDA) published a proposed regulation to amend current manufacturing practice requirements of the Quality System Regulation (QSR) (21 CFR Part 820). The FDA first announced such harmonization in 2018, however COVID-19 delayed the proposal. The FDA seeks to align Part 820 more closely with the international specific standard for medical device quality management systems set out by the International Organization for Standardizations (ISO) 13485. According to the FDA, such “harmonization should provide patients more efficient access to necessary devices, leading to improvements of life quality of the consumers.” Part 820 is part of the current mandatory regulations that ensure that all medical devices created and developed within the US market are safe. ISO 13485 is the international standard for a quality management system for medical devices required by certain countries. Therefore, any manufacturer that sells outside the US will likely need to be ISO 13485 certified. With the implementation of this new amendment, manufacturers would be able to assure their products are regulatorily compliant in both the US and international markets.

Comparing FDA QSR PART 820 and ISO 13485

Both regulations concern the quality, processes, documentation, and good manufacturing practices of medical devices. Generally, the two systems are relatively similar because, in 2016, ISO brought several requirements in line with what the FDA already expected, such as document control and records management in protecting confidential information. However, the international standard has been more rigid because it has taken a more risk-based approach. It requires control of internal processes, validation of computerized systems, and review of training effectiveness. The FDA has expressed great interest in the ISO’s “greater emphasis on risk management activities and risk-based decision making.” The current Part 820 only “explicitly” addresses risk management activities in its section on risk analysis within design validation. FDA clarifies that despite not addressing it, it has expected manufacturers to “integrate risk management activities throughout their quality management system (QMS) and across the total product lifecycle.” Another notable change would be how the FDA would conduct its inspections. Although the FDA will retain the right to conduct inspections of medical devices regulatory compliance, it states in the proposed rule that it intends to replace its current approach through Quality System Inspection Technique (QSIT) with something similar; however, that new approach remains vague.

The Benefits of Harmonizing Medical Device Regulation

Some of the expected benefits of such harmonization include allowing devices certified under ISO 13485 to enter the US market. Currently, a medical device that is IOS 13485 certified has no bearing on whether it is Part 820 compliant. Therefore, such harmonization will allow for collaboration with foreign regulatory authorities, and stronger ties to risk management principles. Furthermore, they have emphasized that this amendment will benefit both manufacturers and patients. In the executive summary released in anticipation of their advisory committee that occurred on March 2, 2022, the FDA wrote that “harmonizing differing regulations would remove unnecessary, duplicative regulatory requirements and impediments to market access and remove barriers to patient access and costs.” The advisory committee also notes that harmonization will allow manufacturers to only comply with “a single set of regulations instead of two different ones.”

Furthermore, unlike ISO, which is updated every couple of years, QSR Part 820 has remained unchanged since 1996. In the proposed regulation, FDA recognizes that in adopting ISO 13485, there could be some inconsistencies with FDA’s statutory and regulatory framework. Therefore, they have incorporated some modifications that include FDA-specific definitions, exclusions of certain manufacturers from design and development, traceability requirements, and labeling and packaging. Furthermore, Part 820 will only harmonize with the 2016 version of IOS 13485 and “any future revisions to this standard would need to be evaluated.” The FDA expects this amendment to provide a more flexible approach to both manufacturers and patients by removing barriers for new technological advancements to enter the US market. And as Wil Vargas of the Association for the Advancement of Medical Instrumentation and Secretary of ISO said, “this announcement will take global harmonization of regulatory requirements in the medical devices sector to a next level.”The public may continue to comment on the proposed regulation until May 24, 2022.