In Force Checked October 24, 2026
Subpart A was updated with the QMSR so that its device provisions refer to the new Part 820.
What It Covers
How CGMP and postmarketing safety reporting apply to products that combine a drug, a device and/or a biological product, so a single manufacturing system can satisfy each constituent’s requirements.
Who It Applies To
Manufacturers of combination products such as prefilled syringes, drug-eluting stents, and autoinjectors.
Key Requirements
- A streamlined approach: operate under drug CGMP or the device quality system, then add the specified provisions of the other (§4.4).
- Under a drug-based system, add device design controls, purchasing controls, CAPA, and related provisions; under a device-based system, add the listed drug CGMP provisions such as testing and stability.
- Subpart B: postmarketing safety reporting that combines the constituent parts’ reporting duties.
What an Auditor Asks to See
- Which approach you chose, and the procedures that implement the added provisions.
- Design control files for the device constituent.
- Reporting decisions that consider both drug and device reporting rules.
Where Systems Fall Short
- Device and drug systems run in parallel, with the joins between them owned by nobody.
- Design controls applied to the device part only after a problem forced it.
How QES Helps
Reconciling the two systems into one, with the added provisions written into the procedures people actually use.
Related Standards
Sources. eCFR — 21 CFR Part 4 (opens in a new tab). Status checked October 24, 2026. This page summarizes 21 CFR Part 4; it does not reproduce or replace it. Buy the standard from its publisher, or read the regulation in its official text, before relying on a detail. Not legal advice.