QMSR Applicable Regulatory Requirements

QMSR Applicable Regulatory Requirements

Our previous post discussed Design Requirements for the Quality Management System Regulation (QMSR). This post will focus on QMSR Applicable Regulatory Requirements. You can see the final QMSR rule here.

Understanding Applicable Requirements

In QMSR section 21 CFR 820.10, Requirements for a Quality Management System, the FDA has incorporated ISO 13485 Quality System requirements while maintaining additional FDA medical device-related regulatory requirements.
In general, the new QMSR requires that manufacturers establish and maintain a quality management system and comply, as appropriate, with all “applicable regulatory requirements,” including, but not limited to, those requirements listed in the proposed QMSR Rule.
Accordingly, manufacturers are responsible for identifying and meeting all applicable requirements, even if such requirements are not specifically mentioned in the 21 CFR 820.10 section.
FDA notes that all sections of ISO 13485 apply to device manufacturers. However, some FDA QS requirements are also required to meet ISO 13485 requirements. For example, compliance with the unique device identification (UDI) provisions (21 CFR 830) is necessary to comply with ISO 13485 Clause 7.5.8  Identification.
Similarly to ISO 13485, QMSR allows for flexibility, and manufacturers can identify and document the requirements that do not apply for them.

Joint ISO 13485 and FDA requirements

Let’s bring some examples of joint ISO 13485 and FDA requirements.
To comply with ISO 13485 Clause 7.5.9.1 Traceability, a manufacturer must document traceability procedures in accordance with the requirements of 21 CFR Part 821, Medical Device Tracking Requirements. In addition, ISO 13485 Clause 7.5.9.2 provides traceability requirements for implantable devices and devices that support or sustain life.

To comply with Clauses 7.2.3 Communication, 8.2.3 Reporting to regulatory authorities, and 8.3.3 Actions in response to nonconforming products detected after delivery, QMSR requires manufacturers to handle advisory notices in accordance with the requirements of 21 CFR Part 806 Medical Device Correction and Removals.

FDA explained that since Parts 803 (Medical Device Reporting), 806 (Medical Device Correction and Removals), 821 (Medical Device Tracking Requirements), and 830 (Unique Device Identification) are particularly relevant to meeting the requirements outlined in the ISO 13485 Clauses listed in 820.10(b), FDA will not make any changes to the listed requirements in these 21 CFR parts.

Proactive Quality Approach 

In light of this, manufacturers must actively explore the entire ISO 13485 standard for the applicable sections or/and binding and complementary FDA requirements.
Failure to comply with the new QMSR requirements in the amended 21 CFR Part 820 (and, by extension, ISO 13485) will render a device adulterated when the QMSR becomes official in 2026.
One of the first tasks for manufacturers during QSR—QMSR gap analysis is to identify operations that are not relevant to the company and those that have not been addressed in the QS yet.

BioReg Services

Don’t hesitate to contact us for assistance with FDA QMSR’s applicable requirements or QS—QMSR Gap Analysis. Our team can provide cost-effective help with all ISO 13485 Transition or other Quality and regulatory Consulting tasks.

BioRegards,

Daniel