RECORDREFERENCE OUTLINE

US Postmarketing Safety Report Decision Record

Decision record for US postmarketing safety reporting that starts where the errors start: which regime governs the product. Covers the drug and biological-product provisions, seriousness and expectedness against the approved labelling version, the awareness date and its evidence, submission, and reconciliation against the safety database. Maps to 21 CFR 314.80 and 21 CFR 600.80.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
21 CFR 314.8021 CFR 600.80
DOCUMENT TYPE
Record
LAST UPDATED
August 2026
PURPOSE

US postmarketing safety reporting for drugs and for licensed biological products runs on parallel regimes with the same architecture but separate legal texts. The recurring finding is not a missed case but a misapplied regime, decided once at intake and never revisited. Which provision governs your product is your determination; this record forces you to state it, evidence it, and carry it through every downstream judgement.

What's Inside

✓Regime determination naming the governing provision and the product characteristic that decides it, recorded once
✓Seriousness and expectedness assessed against a named labelling version, so the comparison can be re-performed later
✓Awareness date with the intake record that evidences it, the applicable window, and the calculated due date
✓Investigation and follow-up log showing what was sought, from whom, and what remained unobtainable
✓Submission table separating expedited, follow-up and periodic reports, each with its acknowledgement reference
✓Reconciliation against the safety database on a defined cadence, with discrepancies carried through to resolution
✓Sign-off by the assessor and the safety function, dated, with any dissent recorded rather than resolved silently

How to Use It

1Determine the governing provision before assessing anything else — 21 CFR 314.80 for drugs, 21 CFR 600.80 for licensed biological products.
2Take the awareness date from the documented intake record, not from case-file creation; the two differ whenever intake and processing sit in different functions.
3Judge expectedness against the currently approved labelling and name the version; a superseded label makes every expectedness call in the file contestable.
4Open the record for a device complaint only to route it — the Medical Device Reporting regime governs there, and neither provision applies.
5File within the window while the investigation remains open, and carry what is learned afterwards in a follow-up report.
6Reconcile submissions against the safety database on a defined cadence; an acknowledgement proves transmission, never completeness of the reportable set.
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Regime Determination
2Seriousness, Expectedness and the Reporting Category
3Awareness Date and Clock
4Investigation and Follow-Up
5Submission and Reconciliation
REGULATORY CONTEXT

21 CFR 314.80 governs postmarketing reporting of adverse drug experiences and 21 CFR 600.80 the equivalent duties for licensed biological products; each sets its own reporting categories and windows. Neither provision decides which regime your product sits under, what your intake records must look like, or when your organisation is deemed aware — those determinations belong to you and must be defensible from the record. The decision-record structure and the regime-determination step are SPEQ’s practitioner synthesis.

MAPPED STANDARDS
21 CFR 314.8021 CFR 600.80
Browse the standards catalog →