21 C.F.R. · Food and Drugs
21 C.F.R. § 822.28

If I stop marketing the device subject to postmarket surveillance, what must I do?

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 822.28 — If I stop marketing the device subject to postmarket surveillance, what must I do?

§ 822.28 If I stop marketing the device subject to postmarket surveillance, what must I do? You must continue to conduct postmarket surveillance in accordance with your approved plan even if you no longer market the device. You may request that we allow you to terminate postmarket surveillance or modify your postmarket surveillance because you no longer market the device. We will make these decisions on a case-by-case basis, and you must continue to conduct the postmarket surveillance unless we notify you that you may stop your surveillance study.

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
Root-LD Entity Data
◈ Machine-Readable Provenance Record Root-LD v1.0 · boisestandard.org
Federation ID
BS-CFR21-SEC-B475B2
Entity Class
REGULATION / FEDERAL-CFR-SECTION
Domain Signature
boisestandard.org
Citation
21 C.F.R. § 822.28
Corpus
CFR — Code of Federal Regulations
Status
✓ ACTIVE
Source
PRIMARY-SOURCE
Source Verified
✓ TRUE
Content Hash
d28e5b37ef4f951e...
Semantic Edges
Pending — corpus passes queued
The regulatory text of 21 C.F.R. § 822.28 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
Navigate Corpus — Title 21 C.F.R.
◈ Provenance
boisestandard.org United States Law CFR Title 21 21 C.F.R. § 822.28