Officials from the US Food and Drug Administration (FDA) answered 21 questions submitted by medical device manufacturers regarding the agency’s Quality Management System Regulation (QMSR), which goes into force for the MedTech industry on Feb. 2.
The FDA published its QMSR in 2024; the new rule harmonizes the current decades-old Quality System Regulation (QSR) with international quality systems standard ISO 13485:2016. (Related Story: “A ‘Major Change’: Is Your MedTech Company Ready for FDA’s Review of Audit Reports?“ QualityHub, Jan. 1, 2026.)
The questions from industry were answered by these five FDA officials at a mid-December webinar:
- Keisha Thomas
- Associate Director for Compliance & Quality, Office of Product Evaluation and Quality (OPEQ)
- Karen Masley-Joseph
- Senior Advisor, Office of Medical Devices & Radiological Health Inspectorate, Office of Inspections and Investigations (OII)
- Kimberly Lewandowski-Walker
- Regulatory Officer, FDA Inspections and Regulatory Audits Team, Office of Regulatory Programs, Office of Product Evaluations and Quality (OPEQ)
- Joseph Tartal
- Deputy Division Director, Division of Industry and Consumer Education (DICE)
- Tonya Wilbon
- Assistant Director for Post-Market Industry, Education and Consumer Education, Division of Industry and Consumer Education (DICE)
[Editor’s Note: The questions and answers below were lightly edited by QualityHub for clarity and brevity.]
🔥 No. 1: Where can companies access ISO 13485:2016 and ISO 9000: 2015?
Keisha Thomas: You can access ISO 13485:2016 in the incorporation by reference portal as a read-only document. That website is listed where you can get it in the final rule, but it’s https://ibr.ansi.org/standards/iso1.aspx. The ISO 9000:2015 standard is available for viewing without cost at the ISO standards website at www.iso.org and you can look for ISO 9000:2015 there.
🔥 No. 2: Will FDA begin enforcing the QMSR on Feb. 2, 2026?
Karen Masley-Joseph: Yes, the Medical Devices: Quality System Regulation Amendments final rule was published on Feb. 2, 2024, with an effective date two years later, which is coming up quickly, on Feb. 2, 2026. In that final rule, it states that the amended regulation will be titled The Quality Management System Regulation, or QMSR, and the QMSR will be effective on Feb. 2, 2026. So again, yes, the FDA will begin enforcing QMSR requirements on Feb. 2, 2026.
🔥 No. 3: Does having an ISO 13485 certification mean a company is automatically compliant with the QMSR?
Kimberly Lewandowski-Walker: No. ISO 13485 certification by itself does not ensure compliance to the QMSR. Manufacturers must comply with all requirements in the QMSR, any other applicable provisions in the Federal Food, Drug, and Cosmetic [FD&C] Act, and its implementing regulations. FDA will not accept ISO 13485 certifications in lieu of conducting [the agency’s] own assessment of a manufacturer’s compliance with Quality Management System [QMS] requirements during inspections.
🔥 No. 4: Does compliance with the QMSR mean a company is certified to ISO 13485?
KLW: The answer here is no. FDA inspections will not result in the issuance of a certificate of conformity to ISO 13485.
🔥 No. 5: Are existing Good Manufacturing Practice, or GMP, exemptions set forth by individual classification regulations superseded by the QMSR?
Joseph Tartal: They are not superseded by the QMSR. Existing GMP exemptions remain under the QMSR. The Code of Federal Regulations will be updated to reflect that the Quality Management System Regulation and current exemptions continue to apply. And this is also noted in the new medical devices Quality Management System Regulation technical amendments that were published [on Dec. 4] and can be found in the Federal Register.
🔥 No. 6: Because the FDA is incorporating by reference ISO 13485:2016, does that mean the FDA is also incorporating by reference additional standards referenced in ISO 13485?
Tonya Wilbon: As previously indicated, the QMSR is incorporating by reference ISO 13485:2016 and Clause 3 of ISO 9000:2015. Other standards referenced are voluntary as usual, and FDA does not in this rulemaking incorporate any other standards referenced by or even listed as a source in ISO 13485 such as ISO 14971 [for risk management].
🔥 No. 7: Where can a company access the final rule?
KT: The final rule for the QMSR is in the Federal Register. You can access the final rule, inclusive of the preamble and all the comments, there. When the Quality Management System Regulation becomes effective on Feb. 2, 2026, the codified version of the regulation will be in … 21 CFR, Part 820 where the Quality System Regulation currently is, and that will be replaced with the Quality Management System Regulation.
🔥 No. 8: Will there be a new FDA facility inspection process?
KMJ: Yes, the FDA will have a new inspection process, and that process will be aligned with the requirements of the QMSR. On Feb. 2, 2026, the current inspection process, which is Quality System Inspection Technique, or QSIT, will be withdrawn, and FDA will implement the new QMSR-aligned inspection process. (Related Story:“FDA to MedTech Companies Waiting to Comply With New QMSR Rule: ‘Don’t Do That’,” QualityHub, April 24, 2025.)
🔥 No. 9: Now that FDA has incorporated by reference ISO 13485:2016, what happens if the standard is revised?
KLW: The FDA will evaluate any future revisions to the standard to determine the impact of any changes and whether we need to amend the QMSR, if appropriate. Amendments to the QMSR will be implemented through the rulemaking process. The good news is that ISO [the International Organization for Standardization] officially confirmed the 2016 version of the standard for another five years. Therefore, ISO 13485:2016 will not be revised until at least April 2030.
🔥 No. 10: Are specific labeling requirements set forth in the current QSR maintained in the QMSR?
JT: The QMSR retains specific labeling and packaging requirements from the Quality System Regulation. These include examining the label to ensure it contains an accurate Unique Device Identifier [UDI] or Universal Product Code [UPC], expiration dates, storage instructions, handling instructions, and any additional processing instructions. Manufacturers must document procedures to ensure labeling accuracy and prevent mix-ups during packaging operations.
🔥 No. 11: The QMSR specifies requirements for inspection of labeling and packaging prior to release or use. Is manual inspection required or can an automated method be used?
TW: FDA included additional requirements for labeling and packaging devices in Sec. 820.45 that were not specifically addressed in ISO 13485:2016. FDA retained the requirements to inspect labeling and packaging for accuracy before use. Document the inspection and release of the labeling to ensure that all devices have correct labeling and packaging and to prevent errors. So the requirement to inspect labeling and packaging does not preclude automatic readers where the process is followed by human oversight. FDA further clarifies that a designated individual, though, must examine – at a minimum – a representative sample of all labels that have been checked by automated readers.
🔥 No. 12: What does “reserved” mean in context of the QMSR?
KT: People that have read the QMSR so far have probably noticed that listed within the … rule itself there are sections that are that are denoted as reserved. “Reserved” is a placeholder term used in the Code of Federal Regulations to indicate that the FDA may insert regulatory information into that location in the future. What it means is it was intentionally left empty right now so that we did not use it currently.
🔥 No. 13: Where do I find information about the new inspection process for QMSR?
KMJ: The QMSR inspection process will be documented in a revised version of the Compliance Program, which is titled Inspection of Medical Device Manufacturers. This revised Compliance Program will be effective on Feb. 2, 2026, and it will be available on the Center for Devices and Radiological Health (CDRH) Compliance Programs webpage.
🔥 No. 14: How does the QMSR impact combination products?
KLW: The QMSR does include conforming edits to 21 CFR, Part 4 for combination products. It should be noted that these changes do not impact the Current Good Manufacturing Practice [cGMP] requirements for combination products.
🔥 No. 15: When it comes to Quality Management Systems, will manufacturers retain flexibility under the QMSR?
JT: One of the things that I love about the [current] Quality System Regulation and … retained in the QMSR is that we retain that scope, allowing manufacturers that flexibility in designing their Quality Management System. [Companies] own it and they need to meet the requirements in the regulation, but they have the flexibility in design.
Designing that system based on factors such as what type of device it is, what the risk is of that device, what the complexity is of the device, what the manufacturing processes are, what the risks and complexities of those manufacturing processes are, and, of course, the size and makeup of the company. So yes, [companies] get to retain that great flexibility and determine what suits them best as long as they meet all the requirements in the regulation.
🔥 No. 16: Does specific identifying information need to appear on each batch or lot of a product?
TW: Sec. 820.35 requires that for each medical device or batch of medical devices the … UDI must be recorded. This is in addition to complying with the requirements of ISO 13485:2016 … in Clauses 7.5.1, 7.5.8, and 7.5.9. This ensures, of course, comprehensive traceability and accountability for every device that is produced. So yes, there is some additional information that must be included.
🔥 No. 17: What are some ways industry can prepare for the regulation change?
JT: You need to know what … the new reg is and then conduct a gap analysis to identify the differences and update your Quality Management System, and revise the processes and procedures to incorporate those changes. And then train staff on those revised processes and procedures and implement those new processes and procedures, as well as monitor … implementation to make sure this is the implementation you want. (Related Story: “FDA Veteran: ‘My Thinking Has Evolved’ on Efforts by MedTechs to Comply With QMSR Rule,” QualityHub, July 9, 2025.)
🔥 No. 18: Are the requirements of 21 CFR, Parts 820.180 and 820.198 still applicable under the new QMSR?
TW: Under the QMSR, although general requirements concerning records under 820.180 and complaint files under 820.198 are no longer numbered, the requirements remain and manufacturers may meet the requirements set forth in those sections by complying with, among other things, 820.35 for control of records and the records and complaint handling portions of ISO 13485.
For example, in the QMSR, requirements for records of complaints can be found in 820.35(a) and Clause 8.2.2 of ISO 13485, as incorporated by reference. So, while the specific numbering of 820.180 and 820.198 are not included in QMSR, those requirements are.
🔥 No. 19: The FDA’s response to Comment 29 in the preamble to the final rule states, “After consideration, we have included in Sec. 820.3 one definition for ‘batch’ or ‘lot’ consistent with the definition of these terms in Sec. 820.3(m) of the QS Regulation.” Some stakeholders say they’ve searched the QMSR for the terms “batch” and “lot” but did not find a definition. Will this definition be added to the QMSR prior to its effective date of Feb. 2?
KT: The preamble accurately states the agency’s intention. However, we have now corrected the missing information in the technical correction for the Medical Devices: Quality System Regulation Amendments that was published in October 2024. So, there was an omission – an administrative error – and that error has been corrected. It has now been updated, and that technical correction has the appropriate information that was omitted previously.
🔥 No. 20: Is there anywhere to obtain a comparison between the quality system requirements and the QMSR?
KLW: At FDA, we do not have a formal side-by-side comparison between the requirements in the quality system regulation and the QMSR. So as manufacturers you would need to perform an appropriate gap analysis for your system and identify those gaps and comparative sections.
🔥 No. 21: Will an Investigational Device Exemption, or IDE, that has been approved under 21 CFR, Part 812 still require compliance with design controls when the QMSR comes into force?
JT: The short answer is yes. IDEs approved under Part 812 will be required to comply with design and development requirements in the QMSR. So, if you look through the Quality System Regulation, it talks about design controls, and now the QMSR talks about design and development. Both will be required when you’re doing your Investigational Device Exemption because when you’re doing any type of design work, it’s not retrospective – you’re doing it prospectively. So, the short answer is yes, you’re going to have …. Part 812 design and development requirements in the QMSR under 21 CFR, Part 820.10(c), which directs manufacturers to the requirements set forth in ISO 13485, Clause 7.3.