QMSR and the CP 7382.850 Inspection Process

1. Key takeaways

According to the FDA Device Regulation Overview page, as of February 2, 2026, FDA discontinued the use of the Quality System Inspection Technique (QSIT) and adopted the inspection process described in the Compliance Program for the Inspection of Medical Device Manufacturers: 7382.850. At the same time, FDA retired 7382.845 (Inspections of Medical Device Manufacturers) and 7383.001 (Pre-approval and Post-approval Inspections for Device PMA). This is a simultaneous change on a single date: the old inspection technique, two legacy compliance programs, and the old quality system regulation all stop applying together, which means preparation work cannot be staged gradually across the change date. Manufacturers, including those outside the United States, face the new inspection approach and the new quality system requirements at the same time. The single date is the anchor for every preparation task, and each task should be scheduled backward from it.

2. Legal basis

The change described here rests on the following FDA documents and regulatory provisions, all in force or effective as of the verification date noted at the end of this page. Together they define both the requirements FDA expects manufacturers to meet and the method its investigators use to verify them.

3. Expert insights

Insight one: three documents switch on the same day; this is not a gradual replacement.

As stated on the FDA page, from February 2, 2026, FDA ended its use of QSIT and began using the process described in 7382.850; after that date, FDA no longer uses 7382.845 or 7383.001. This is a same-day switch, not a transition period. There is no window in which the old and new inspection approaches operate side by side, so any preparation plan that assumes a phase-out period for the legacy programs is built on the wrong premise. The practical estimate for readiness work is that everything must be aligned to the new documents before the effective date, not after it. Teams should archive or clearly mark legacy QSIT training materials to prevent them from being used for preparation of an inspection conducted under the new program.

Insight two: the retirement of 7383.001 means the PMA-specific inspection process is folded into the unified process.

7383.001 was the compliance program for Pre-approval and Post-approval Inspections for Device PMA. With its retirement, coverage is consolidated under 7382.850, which means PMA establishments and other device establishments are brought into the same inspection procedure. PMA holders who previously prepared for inspections using a dedicated program should retrain their teams on the unified process, because the structure and emphasis of the inspection they will now face follows the new program rather than the PMA-specific one they may know well. The unified process also simplifies internal preparation for companies holding multiple submission types, since a single rehearsal framework now serves all of them.

Insight three: the change to the inspection process and the change to the system requirements are two faces of the same revision.

The revision of 21 CFR Part 820, which incorporates ISO 13485:2016 by reference, changes the requirements; 7382.850 changes the inspection method. Both take effect on the same day, and companies must therefore align both dimensions at once: reorganize their system documentation according to the clause structure of ISO 13485:2016, and rehearse their inspection readiness according to 7382.850. The two changes are described together on the same FDA page and should be read as one package.

Treating these as two separate projects with separate timelines risks finishing one while the other remains unfinished, and the inspection will examine both together. A gap analysis that maps each ISO 13485:2016 clause to existing procedures, followed by an inspection rehearsal against 7382.850, addresses both dimensions in sequence and keeps the two workstreams coupled.

Insight four: foreign manufacturing sites are equally covered.

The official FDA page states explicitly that foreign manufacturing establishments are subject to FDA establishment inspections. The change in the inspection process applies in the same way to foreign companies and to companies based in the United States, pending verification against the latest guidance for each site. For foreign manufacturers, this means the same rehearsal and documentation alignment work is required, and the distance from FDA offices does not reduce the expectations applied during an inspection of the site. Scheduling the rehearsal before any inspection is announced is the practical way to avoid compressing the work into a notification window.

4. Practical recommendations

• Reorganize system documentation according to the clause structure of ISO 13485:2016, rather than relabeling legacy QSR documents, so the mapping between the standard and the procedures is explicit.
• Conduct a mock inspection following the process of CP 7382.850, replacing the previous QSIT-style preparation.
• Update internal document inventories, removing references to 7382.845 and 7383.001 so no procedure points staff to a retired program.
• Carry out 7382.850 rehearsals at foreign manufacturing sites on the same schedule as domestic sites.
• Fold PMA inspection preparation into the unified process and stop preparing for it separately.

5. Verification checklist

• □ 2026-02-02 has been confirmed as the process switch date
• □ System documentation has been reorganized according to the clause structure of ISO 13485:2016
• □ A mock inspection according to CP 7382.850 has been completed
• □ References to 7382.845 and 7383.001 have been removed from internal document inventories
• □ Foreign manufacturing sites have rehearsed on the same schedule
• □ PMA inspection preparation has been folded into the unified process

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, US Agent and local testing support for the United States market. Our team manages FDA establishment registration and listing, 510(k)/De Novo/PMA submissions, and supports post-market reporting obligations. Business enquiries: info@grzanglobal.com