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Overview
The FDA recognizes the benefits of harmonization with other regulatory authorities, and it has determined that ISO 13485:2016, the globally recognized standard for a medical device organization’s QMS, is substantially similar to the current version of 21 CFR Part 820 which became effective in 1996.
To promote consistency with its regulatory counterparts, the FDA is transitioning from the existing 1996 version of 21 CFR Part 820, the Quality Management Regulation, to the updated 21 CFR Part 820, the Quality Management System Regulation (QMSR) which will become effective on February 2, 2026. The QMSR will incorporate by reference ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes.
The QMSR adds additional definitions and provisions to meet FDA’s statutory and regulatory framework. Therefore, medical device manufacturers must prepare for the transition to the QMSR, even those who are currently certified to ISO 13485:2016.
FDA is incorporating ISO 13485 into the current QSR “by reference,” meaning the new QMSR will address certain requirements by referencing their location in ISO 13485:2016. This will, of course, result in substantial changes to 21 CFR Part 820 as we know it.
The good news is, many of these changes are semantic in nature and don’t change the basic QMS requirements for medical device companies. For instance, you’ll notice that the terms device master record (DMR), design history file (DHF), and device history record (DHR) don’t appear in the final rule.
That doesn’t mean, however, that the documentation requirements of the DMR, DHR, and DHF have been eliminated. FDA simply believes those requirements are adequately described in ISO 13485 and will be covered by the catch-all term Medical Device File (MDF).
On the other hand, there are terms and definitions in ISO 13485 that “could create inconsistencies with FDA’s statutory and regulatory framework.”
In these cases, the FDA’s definitions will supersede those of ISO 13485. For example, ‘device’ and ‘labeling’ will supersede the definitions for ‘medical device’ and ‘labelling’ in ISO 13485.
The Final Rule also includes several new sections in Part 820:
Section 820.7 – Incorporation by reference
Section 820.10 – Requirements for a quality management system
Section 820.35 – Control of records
Section 820.45 – Device labeling and packaging controls
February 2026 will be here sooner than you think, so it’s worth it to start looking at your current labeling and packaging procedures now—and start getting them in line with what will be expected.
Will FDA Inspections Change Under the QMSR?
Most likely FDA inspections will feel different once the FDA completes their training and preparation for QMSR. FDA currently uses and inspection approach called the Quality System Inspection Technique (QSIT). This is being eliminated or revised to align with the QMSR but this work is not yet complete and/or public information. In any case, you should not assume that FDA inspections will be any less strenuous following the amended regulation or that companies that have existing ISO 13485:2016 certificates will be exempt from inspections. Note that FDA will not be issuing QMSR compliance certificates.
Here’s a step-by-step strategy to achieve compliance with the updated regulation:
1. Understand the QMSR Requirements in Detail
Begin by thoroughly reviewing the QMSR final rule to understand the new requirements and how they differ from the current regulations.
Focus on incorporating ISO 13485:2016—and the standards it references—into the FDA’s regulatory framework, noting any specific additions or exceptions made by the FDA to align with the FD&C Act and other applicable FDA requirements.
2. Conduct a Gap Analysis
Conduct a comprehensive gap analysis comparing your current quality management system against the new QMSR requirements, including the specifics of ISO 13485:2016, the standards it references and intersects with (such as ISO 14971,) and any additional FDA-specific requirements,
Identify areas of non-compliance and areas that require updates or changes in your procedures, documentation, and quality management practices.
3. Develop an Implementation Plan
Based on the gap analysis, develop a detailed implementation plan that outlines the steps needed to achieve compliance.
This plan should include timelines, responsibilities, resources required, and any training needs. Prioritize actions based on the gap analysis findings and the impact on your quality management system.
4. Train the Team
Educate and train your staff on the new requirements and any changes to your quality management system. This includes training on ISO 13485:2016 and specific FDA regulatory requirements that are now part of the QMSR.
Ensure that personnel involved in design, manufacturing, quality control, and regulatory compliance are fully aware of the new requirements and their roles in maintaining compliance.
5. Update Your Quality Management System
Implement the necessary changes to your quality management system based on the gap analysis and training.
This may involve updating or creating new procedures, documentation, quality policies, and practices to align with the QMSR and ISO 13485:2016 requirements.
6. Plan and Conduct Internal Audits
Conduct internal audits to verify that the changes made to your quality management system are effectively implemented and that your system is fully compliant with the new requirements. Use the audit findings to make any necessary adjustments or corrections.
7. Prepare for FDA Inspections
Ensure your firm is prepared for FDA inspections by maintaining comprehensive and accessible records of your quality management system activities, including training records, audit reports.
QSG’s training provides in-depth insight relative to the content and implementation of the new Quality Management System Regulation including: the purpose, scope and goals of the new regulation; the major provisions and changes associated with the new regulation; the effective date of the new regulation; a discussion of the term “incorporation by reference” (IBR); reference to guidance on the implementation of ISO 13485:2016 within a quality management system; rules for understanding which terms and definitions will be used; FDA’s policy for addressing changes to ancillary regulations, policies, etc. impacted by the new regulation; quality management system regulatory requirements beyond ISO 13485:2016; and, how changes to the CGMPs impact 21 CFR Part 4 Regulation of Combination Products.
The following FDA QMSR workshop is now available:
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