FDA harmonizes medical device QMS requirements with regulation revision
In an effort to further harmonize and modernize quality system regulations, the Food and Drug Administration (FDA) has issued a final rule to amend the medical device current good manufacturing practice (CGMP) requirements of the Quality System Regulation (QSR) i.
While not replacing the existing 21 CFR 820 regulation, the amendment more closely aligns the United States with the QMS requirements of ISO 13485:2016, which is followed by the majority of health authorities globally ii. The revised Part 820 will be referred to as the Quality Management System Regulation (QMSR).
Closer convergence
The QMSR final rule follows earlier steps by the FDA and other international regulators to harmonize certain key QMS activities. Specifically, the FDA and four other regulatory authorities created a single audit program known as Medical Device Single Audit Program (MDSAP) iii. The other authorities include Australia’s Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and Health Canada.
The purpose of MDSAP is to enable qualified auditing organizations to carry out an evaluation of a manufacturer’s QMS for the particular site and evaluate it against all five participating countries iv. The basis for audit program is ISO 13485:2016. The objective behind MDSAP is to achieve a more harmonized QMS, while still accounting for the unique expectations of each country. The MDSAP audit approach sets out instructions for performing audits in participating countries, as well as specific differences.
By way of example, Brazil has unique requirements that “any consultant who gives advice regarding design, purchasing, manufacturing, packaging, labeling, storage, installation, or servicing of medical devices has proper qualification to perform such tasks v”. That means manufacturers must provide objective evidence that they have met the Brazilian requirement, above and beyond the general requirements that come out of ISO 13485.
While country-specific requirements remain, the QMSR now brings FDA into closer alliance with its MDSAP partners.
A step forward for industry
The QMSR becomes effective on February 2, 2026, two years from the date the FDA’s final rule was published. After that date, FDA will expect manufacturers to have incorporated the new requirements and will assume enforce compliance. The agency has made clear in the final rule that manufacturers are expected to identify and meet all applicable requirements from ISO 13485.
The new ruling inevitably does mean some change for industry.
As a result of incorporating ISO 13485 by reference, many QSR-specific terms, such as design history file, device manufacturing record, and device history record will be eliminated.
One of the most notable changes is the inclusion of some activities that previously were considered to be out of scope from an FDA inspection standpoint. This includes management reviews, internal quality audit reports, and supplier audit reports, which manufacturers will need to start providing to FDA.
In some instances, the QMSR requirements go beyond what is currently required in ISO 13485, including retaining several requirements pertaining to complaint records and device labeling and packaging controls.
While there will be some adaptation for industry, the QMSR final rule is largely good news for manufacturers, since it harmonizes requirements, which in turn makes it easier to be in compliance when distributing products in different countries. Additionally, the QMSR provides for some flexibility over what was previously required in the QSR. For example, under the QMSR, manufacturers are not required to have an independent reviewer at each design review.
Manufacturers will not be required to certify their quality management system to ISO 13485 in order to be compliant with the new QMSR.
It is also important to note that regardless of whether companies are certified to ISO 13485 or as part of MDSAP, FDA still reserves the right to inspect manufacturers. As noted in the final rule, FDA intends to replace its current inspection approach for medical devices, Quality System Inspection Technique or QSIT, with an inspection approach that will be consistent with the requirements of the QMSR.
Preparing for the final rule
The FDA has sought to pre-empt questions from industry with a Q&A published days before the final rule was issued vi. Among these are the development of a new inspection process to align with the QMSR requirements and potential amendments if the ISO standard is revised.
While the Q&A addresses training of FDA staff, the agency has not, as yet, made mention of training for industry. It seems likely that such training will be forthcoming or, at the very least, industry will establish training programs to support manufacturers with the rule changes.
How will the QMSR impact your processes? And what questions do you have about the changes? Have you conducted or thought about a gap assessment to determine how the changes will impact your processes? We would be interested in hearing from you.
About the author
John Lockwood is Senior Director, US Head of MedTech, Cencora PharmaLex. John has more than 25 years of experience in quality, regulatory, operations, and development roles in the life sciences industry, including at Abbott Laboratories and Roche Diagnostics. He holds professional certifications from RAPS and ASQ and has a Bachelor of Science in Chemistry from the University of Illinois.
Notes
i Medical Devices; Quality System Regulation Amendments, Federal Register, 2 Feb 2024. https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments
ii ISO 13485:2016. ISO. https://www.iso.org/standard/59752.html
iii MDSAP Audit Approach. https://www.fda.gov/media/166672/download?attachment
iv Medical Device Single Audit Program (MDSAP), FDA. https://www.fda.gov/medical-devices/cdrh-international-affairs/medical-device-single-audit-program-mdsap
v MDSAP Audit Approach. https://www.fda.gov/media/166672/download?attachment
vi Quality Management System Regulation: Final Rule Amending the Quality System Regulation – Frequently Asked Questions, FDA, https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked
