Recent FDA Amendment Could be a Win for Manufacturers and End Users

In January 2024, the Food and Drug Administration (FDA) issued a final rule amending the current Good Manufacturing Practice (cGMP) requirements for the Quality Management System Regulation (21 CFR 820). The scope of the amendment was to align more closely with ISO 13485:2016, the International Organization for Standardization’s (ISO) requirement for Quality Management Systems.

The ruling was made when the FDA determined that the requirements of ISO 13485:2016 were materially similar to 21 CFR 820 and provide an equal level of assurance in the quality, safety and effectiveness of devices manufactured by complying organizations. The rule becomes effective on February 2, 2026, and will be referred to as Quality Management System Regulation (QMSR).

 Why the Change?
The FDA has long recognized the value of a coordinated regulation of devices. This has been noted in the development of the Global Harmonization Task Force (GHTF), which is charged with implementing the guidance outlined in a document titled “Implementation of Risk Management Principles and Activities Within a Quality Management System.”

In 2012, the FDA developed a voluntary audit report submission pilot program. Through this program, the FDA accepted the ISO 13485:2003 audit report from manufacturers to establish feasibility of the standard in lieu of regular inspections.

Another regulatory group that abides by a similar structure is the Medical Device Single Audit Program (MDSAP). MDSAP is a program that allows organizations (e.g., medical device manufacturers) to complete a single regulatory audit that satisfies the relevant requirements of those authorities participating in MDSAP. Under MDSAP, many third-party audits are conducted based on core ISO 13485 requirements with additional conditions that must be met. When determining whether to enroll in MDSAP, the FDA reviewed QS Regulation (21 CFR 820) and ISO 13485 closely, finding many similarities between the two requirements.

Along with the administrative streamline of amending the QS regulation, the amendment is projected to yield annualized net-cost savings of approximately $532 million at a 7% discount rate, and approximately $554 million at a 3% discount rate. In addition to quantitative cost saving measures, a qualitative benefit of the amendment is faster and easier access to newly developed medical devices for patients, ideally leading to improved quality of life.

 How Can Dayspring Technology Help?
With this ruling, it is clear the FDA’s intent is to create a cohesive standard for medical device manufacturers. By benefiting medical device manufacturers, a positive byproduct may be found in how fast new medical devices enter the market and begin to improve the quality of life for potential users.

Dayspring’s roster of consultants totals nearly 50 years of combined experience with ISO 13485, along with many other ISO standards and overseeing Quality Management Systems.

We use our expertise to evaluate your current QMS against the standard, analyze processes currently in place at your organization and fill any identified gaps. This could include documentation, test workflows, conduct necessary audits and reports, create/modify metrics and guide/represent your organization through the audit certification process.

Changes to Management Systems can be challenging and we are here to help. With the rule scheduled to be in place in early 2026, now is the time for organizations to plan for the change and align their Quality Management Systems. Is your organization in compliance with the new ruling? Do you need help auditing or implementing the requirements in your existing Quality Management System? Are you preparing to put a new Quality Management System into operation and how will you ensure these new requirements are considered in the technology build? Dayspring can help you tackle all these scenarios and more. Email us to learn more or to speak with one of our consultants: consulting@dayspringtechnology.com.

Sources and Other Helpful Information

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

https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments

https://www.fda.gov/medical-devices/cdrh-international-affairs/medical-device-single-audit-program-mdsap#:~:text=The%20Medical%20Device%20Single%20Audit,authorities%20participating%20in%20the%20program.

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