Short answer: 21 CFR Part 820 still exists, and it is now the QMSR. FDA did not delete Part 820 on February 2, 2026. It replaced most of its contents with references to ISO 13485:2016. Six sections still carry their own text, because FDA concluded ISO 13485 did not fully cover them:
820.1 Scope
820.3 Definitions
820.7 Incorporation by reference
820.10 Requirements for a quality management system
820.35 Control of records
820.45 Device labeling and packaging controls
Everything else in Part 820 is marked “Reserved,” which means it points you to ISO 13485:2016 without adding anything. This article walks through the six sections that are left, then covers what inspections look like and whether you still need an independent design reviewer.
The Quality Management System Regulation (QMSR) took effect on February 2, 2026. On that date the old Quality System Regulation (QSR) was removed from 21 CFR Part 820 and the QMSR came into full force.
Part 820 itself did not go anywhere, but it looks very different now. That is because FDA incorporated ISO 13485:2016 by reference. Instead of a written requirement for each part of your quality system, Part 820 now points to the section of ISO 13485:2016 where that requirement lives.
Overall, Part 820 is now much shorter; most of the text simply directs you to ISO 13485. However, there are some sections of the QMSR that the FDA felt ISO 13485 did not fully cover. In these cases, there are sections in Part 820 that include further explanation or requirements not included in ISO 13485.
In this article, I’ll walk through these sections and what you need to know about them, as well as answer some common questions about inspections and independent reviewers.
What’s in Part 820 that isn’t covered by ISO 13485:2016?
This is what the table of contents for Part 820 looks like in the Final Rule for QMSR:
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When a section is “Reserved,” that means it will direct users to ISO 13485:2016 without additional information or requirements. The sections that are left all have important information in them that is not covered in ISO 13485. Here’s what you need to know about them:
Section 820.1: Scope
Section 820.1 - Scope: Here the FDA lays out the applicability of the regulation and its scope.
Section 820.3: Definitions
Section 820.3 - Definitions: This section notes that the regulation is using the definitions from ISO 13485:2016 and Clause 3 of ISO 9000:2015. However, the FDA has also included some definitions here that are not used in either standard.
Section 820.7: Incorporation by reference
Section 820.7 - Incorporation by reference: this section simply states that most of the content in Part 820 has been removed and replaced with references to their location in ISO 13485:2016 and ISO 9000:2015. It also provides instructions on how medical device companies can obtain the standards.
“But what happens if ISO updates 13485 again?” was one of the biggest questions from industry after FDA first announced they were harmonizing Part 820 with ISO 13485:2016. The FDA has responded that they will evaluate any revisions to the standard and determine whether they need to amend the QMSR when the time comes.
Section 820.10: Requirements for a quality management system
Section 820.10 - Requirements for a quality management system: This section states that medical device companies are still subject to other FDA regulations such as:
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21 CFR Part 803 - Medical Device Reporting
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21 CFR Part 806 - Medical Devices; Reports of Corrections and Removals
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21 CFR Part 821 - Medical Device Tracking Requirements
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21 CFR Part 830 - Unique Device Identification (UDI)
820.10 also extends the ISO 13485:2016 traceability requirements for implantable devices to devices that support or sustain life. Finally, this section is where FDA states that failure to comply with QMSR will render a device “adulterated” and subject to regulatory action.
Section 820.35: Control of records
Section 820.35 - Control of records: Here, the QMSR defines content requirements for complaint records (including when complaints should be investigated) and service records explicitly. This is actually more detailed and explicit than what is in the current QSR, so it is worth reading this section carefully.
Section 820.45: Device labeling and packaging controls
Section 820.45 - Device labeling and packaging controls: The FDA did not find ISO 13485’s requirements for device labeling and packaging controls to be adequate, so they have added requirements to the QMSR. Specifically, the FDA wants to ensure that QMSR requires manufacturers to inspect the accuracy of device labels with respect to certain elements prior to release, along the lines of Part 820.120(b) in the QSR.
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What will inspections under QMSR look like?
To be clear, nothing is changing about the FDA’s authority to inspect sites and facilities. However, the Quality System Inspection Technique (QSIT) was officially withdrawn on February 2, 2026, when the QMSR took effect.
FDA has created a new document in its place: the updated Inspection of Medical Device Manufacturers Compliance Program (CP), numbered 7382.850. For what investigators will look for under that program, see What FDA investigators will look for under QMSR.
A few points to remember here:
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FDA inspections will not provide you with an ISO 13485 certification.
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If you are ISO 13485-certified, that does not exempt you from FDA inspections.
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If you are part of the Medical Device Single Audit Program (MDSAP), you will continue to be exempted from routine FDA inspections.
For those not familiar, MDSAP is a program that was started with the goal of streamlining the audit process for companies with products in multiple markets. MDSAP allows these companies to undergo a single audit that is accepted by the members of the program, which include:
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Therapeutic Goods Administration of Australia
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Brazil’s Agência Nacional de Vigilância Sanitária
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Health Canada
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Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
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U.S. Food and Drug Administration
Just keep in mind that FDA only exempts MDSAP participants from routine inspections. You will still be subject to premarket inspections and for-cause inspections by FDA.
Finally, there is one more change to audits that you should be aware of. Internal audits, supplier audits, and management reviews are now fair game during inspections. Under QSR these were exempt from the FDA during inspections per Part 820.180(c), but that language is gone from the QMSR. If your company used that exemption to discuss sensitive subjects during internal audits or management reviews, those records are now open to FDA during an inspection. If you have not already adjusted how those meetings are documented, that is the gap to close first.
It’s worth noting here that the FDA released a draft guidance for Premarket approval (PMA) and Humanitarian Device Exemption (HDE) submissions in October 2025. The guidance is intended to assist medical device companies in preparing their QMS for QMSR and providing the appropriate information in their marketing submissions to the FDA.
At the end of the guidance, in sections VII and VIII, the FDA has included information on how companies with high-risk devices should address Part 820.10 and Part 820.35 in their marketing submissions. This is definitely worth checking out if you have a high-risk device that requires a PMA or HDE submission under the QMSR.
“But what happens if ISO updates 13485 again?” was one of the biggest questions from industry after FDA first announced they were harmonizing Part 820 with ISO 13485:2016. The FDA has responded that they will evaluate any revisions to the standard and determine whether they need to amend the QMSR when the time comes. However, we won’t need to worry about that anytime soon. ISO 13485:2016 was reviewed and confirmed in 2025, and won’t be up for review again until 2030.
Do you still need an independent reviewer?
This is a question that has popped up regularly since the Final Rule for QMSR came out in 2024. The “independent reviewer” here refers to a person within your organization who reviews a product’s design, or section of design, during a design review. This person is not responsible for any of the work on the design stage being reviewed, which is what makes them independent.
This requirement is found in section 820.30(e) of the QSR. However, it is nowhere to be found in the QMSR. ISO 13485:2016 does not require an independent reviewer, which means that one could argue it is no longer required at all.
However, it’s hard to believe that the FDA will let this go. Using an independent reviewer is a well-established best practice in medical device development, and there is evidence that the FDA will still expect companies to use one.
In the preamble of the Final Rule, the FDA answers a question on the independent reviewer by stating:
FDA agrees that the final QMSR differs from the previous QS regulation and does not include the explicit requirement that each stage of design review must include an individual(s) who does not have direct responsibility for the design stage being reviewed. We note that Clause 7.3.5 of ISO 13485 requires that design and development review include representatives of functions concerned with the stage under review as well as other specialist personnel… FDA considers that a successful quality management system under Clause 7.3.3 and 7.3.4. will require a similar approach to design review and validation as those developed under the QS regulation.
An honest interpretation of this is that FDA still expects an independent reviewer, even if there is not an explicit clause in QMSR stating that you must have one.
BONUS: If you still have questions about QMSR and how to prepare your QMS, then check out our QMSR Resource Hub, where we've compiled everything you need to understand what's changing, what's at stake, and how to stay compliant.
Frequently asked questions about QMSR inspections
What do FDA inspections look like under the QMSR?
FDA's authority to inspect did not change. The Quality System Inspection Technique (QSIT) was withdrawn on February 2, 2026. In its place, FDA issued the updated Inspection of Medical Device Manufacturers Compliance Program (CP) 7382.850. Expect quality system inspections to continue under that program. See What FDA investigators will look for under QMSR for what investigators will look for.
Does ISO 13485 certification exempt me from FDA inspection?
No. An ISO 13485 certificate does not exempt you from FDA inspection, and an FDA inspection does not result in an ISO 13485 certificate. They are separate systems.
Does MDSAP participation still exempt me from FDA inspections?
Participation in the Medical Device Single Audit Program continues to exempt you from routine FDA inspections only. You remain subject to premarket inspections and for-cause inspections.
Are internal audits and management reviews still protected from FDA review?
No. Under the old QSR, section 820.180(c) exempted internal audit reports, supplier audit reports and management review records from FDA review during a routine inspection. That language is not in the QMSR.
Do I still need an independent reviewer for design reviews?
The QMSR does not carry forward the explicit requirement at former section 820.30(e), and ISO 13485:2016 does not require an independent reviewer by that name. In the preamble to the final rule, however, FDA indicated it expects an approach to design review comparable to what manufacturers developed under the QS regulation. Treat independent review as an expectation rather than an eliminated requirement.
Get a modern QMS built for medtech regulations
While you’re thinking about the changes you need to make to comply with the QMSR, it also makes sense to take a step back and look at the QMS solution you’re using.
Is it built specifically for medtech? Does it help you achieve truly paperless audits? Does it come with a top-notch team of medical device experts who are always ready to help?
If you answered ‘no’ to any of those questions, it’s probably time to modernize your QMS.
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Your QMSR Readiness Playbook
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