FilePreserve
This is a general reference, not legal advice. Retention rules depend on
your specific facts (device classification, contract terms, state law, litigation holds,
and more) and change over time. Verify retention requirements with your own compliance or
legal team before disposing of anything. Nothing on this page should be treated as a
substitute for reading the actual regulation that applies to your organization.
Estimated earliest date the retention window ends:
Reference table
These are the specific, citable figures this calculator uses. If your record type isn't one of the first two rows, we deliberately don't invent a number — periods vary too much by jurisdiction, contract, and record type to guess.
| Record type | Retention period | Source |
|---|---|---|
| FDA quality system records (device manufacturers), including CAPA and complaint files | Commonly 2+ years from commercial release, or device design life if longer — but this is now set by your own Quality Management System, not a fixed number in the CFR (see note below) | 21 CFR § 820.35 |
| Medicare Advantage books/records, incl. risk-adjustment (RADV) supporting documentation | 10 years | 42 CFR § 422.504(d), (e)(4) |
| Anything else | Varies — check your specific requirement | No single citable default |
A word on the two clocks that don't quite match a simple date calculator:
- FDA quality system records — FDA's Quality Management System Regulation (QMSR) harmonization, effective February 2026, removed the old 21 CFR § 820.180's explicit "2 years / design life" text. Record-keeping is now governed by 21 CFR § 820.35 ("Control of records"), which in turn defers to ISO 13485:2016 Clause 4.2.5 — a standard incorporated by reference, not reproduced in the CFR itself, so no universal public retention number exists anymore. The 2-year/design-life figure shown here is the commonly used industry baseline that predated this change, offered as a reasonable estimate — not a current legal citation. Check your own quality management system's documented retention policy for the number that actually applies.
- Medicare Advantage / RADV records — the regulation's 10-year clock runs from the end of the relevant contract period (or completion of an audit, if later), not from when an individual document was created. This calculator uses the creation date you enter as a rough stand-in; for an actual compliance deadline, calculate from your contract's end date instead.
This is the manual version. FilePreserve automates it.
FilePreserve is a Salesforce managed package that archives files to your own S3 bucket, tracks retention periods and legal holds per archive job, and only disposes of a file once its retention window has actually ended — automatically, with an audit log of every attempt.