The inspection manual changed, not the rule

21 CFR 820 read differently after February 2, 2026 — Part 820 kept its numbers and lost most of its own text, replaced by an incorporation of ISO 13485:2016. That is a change to the regulation itself, and it is not the only thing that changed that day. The document that tells an FDA investigator what to actually check, in what order, and against what evidence during a device-manufacturer inspection changed too — and it changed by a completely different mechanism, one that never touches the Federal Register at all.

QSIT is retired

For decades, an FDA inspection of a device manufacturer ran on the Quality System Inspection Technique — QSIT — formalized as Compliance Program 7382.845, with a separate compliance program, 7383.001, covering PMA preapproval and postmarket inspections. Effective February 2, 2026, alongside the Quality Management System Regulation, FDA withdrew both and replaced them with a single document: Compliance Program 7382.850, Inspection of Medical Device Manufacturers. An investigator opening a case today is not working from the QSIT playbook a quality department may still keep on file. That playbook was retired the same day the regulation it inspected against was rewritten.

Why no Federal Register notice announced it

A final rule amending 21 CFR 820 has to go through notice-and-comment rulemaking — a proposed rule, a comment period, a final rule with a preamble responding to what came in. FDA’s compliance programs do not run on that track. They are internal guidance to FDA’s own field staff, and FDA’s good guidance practices regulation, 21 CFR 10.115, lets a document that sets out existing practice or an operational procedure take effect on posting, with no requirement that its availability be announced in the Federal Register first. The 820 rewrite was public for two years before it took effect, carried through proposed rule, public comment, and final rule in turn. The compliance program it depends on for enforcement showed up on FDA’s own site with no equivalent runway — public because FDA chose to publish it, not because notice-and-comment required it to be.

The rule a manufacturer studies and the manual an investigator studies do not have to move on the same calendar, and as of this year they did not.

The practice

None of FDA Radar’s four sources — Federal Register notices, warning letters, device recalls, 510(k) clearances — carries a compliance program. A rewrite like this one produces no docket, no comment deadline, no item that would ever reach a monitoring feed built to watch those four things; it exists as a single PDF posted to FDA’s compliance-manuals page, dated only by the document itself. An audit-prep deck that still walks a team through QSIT’s subsystem structure is preparing them for an inspection method FDA does not currently use. The practice is not complicated — read Compliance Program 7382.850 directly, the same way this column has argued for reading any primary source directly, rather than assuming an inspection methodology holds steady just because the regulation it audits against is the one everyone has been discussing all year. What a specific inspection under the new program means for a specific facility is a judgment for the regulatory or quality professional running that audit; this is a description of which document changed and how, never advice about what to do differently because it did.