Skip to content
CROSSWALK

21 CFR Part 822 §822.27

Maps to

21 CFR Part 822: §822.27 If I go out of business, what must I do?

Requirement text

A manufacturer subject to a postmarket surveillance order that decides to close its business must notify FDA within 30 days of that decision. The notification should provide the expected date of closure and should discuss plans for completing or terminating the postmarket surveillance. The manufacturer must also identify who will retain the surveillance records and where those records will be kept after closure.

21 CFR § 822.27 — current eCFR →

Related clauses

MDR Reporting Requirements — General ObligationsWritten MDR ProceduresMDR Event Files and Records RetentionManufacturer MDR Reporting — Adverse Event Investigation and Submission5-Day Expedited MDR ReportsReports of Corrections and Removals

Join the waitlist to check your documents against this clause →

Further reading

A free structural scan is coming.

No credit card. No sales call. No consultants required.

We'll notify you when the scanner launches. No spam.