FDA Postmarket CFR → ISO 13485 Crosswalk
Each postmarket CFR section with the ISO 13485 clause the same evidence satisfies — regulatory reporting, complaint handling — and those with no counterpart.
Group by:
Measurement, Analysis & Improvement
| CFR Section | ISO 13485 Clause | Requirement | Common Gaps | Details |
|---|---|---|---|---|
| §803.10 | 8.2.3 | MDR Reporting Requirements — General Obligations | — | View → |
| §803.17 | 8.2.3, 8.2.2 | Written MDR Procedures | — | View → |
| §803.18 | 8.2.3 | MDR Event Files and Records Retention | — | View → |
| §803.50 | 8.2.3, 8.2.2 | Manufacturer MDR Reporting — Adverse Event Investigation and Submission | — | View → |
| §803.53 | 8.2.3 | 5-Day Expedited MDR Reports | — | View → |
| §806.10 | Reports of Corrections and Removals | — | View → | |
| §806.1, 806.20 | Records of Corrections and Removals Not Required to Be Reported | — | View → | |
| §806.30 | FDA Access to Corrections and Removals Records | — | View → | |
| §810.10, 810.11, 810.12, 810.14, 810.15, 810.16 | Cease Distribution and Notification Order — Compliance Obligations | — | View → | |
| §810.13, 810.14, 810.16, 810.17 | Mandatory Recall Order — Strategy and Status Reporting | — | View → | |
| §822.1, 822.4, 822.5, 822.8, 822.9, 822.17, 822.19, 822.24 | Postmarket Surveillance Order — Applicability and Plan Submission | — | View → | |
| §822.3, 822.10, 822.11, 822.15, 822.21, 822.31 | Postmarket Surveillance Plan Content Requirements | — | View → | |
| §822.31, 822.33, 822.35, 822.36, 822.38 | Postmarket Surveillance Records and Reporting Obligations | — | View → | |
| §822.26 | Postmarket Surveillance — Change of Ownership Notification | — | View → | |
| §822.27 | Postmarket Surveillance — Business Closure Notification | — | View → | |
| §822.28 | Postmarket Surveillance — Obligation Continues After Ceasing to Market | — | View → | |
| §822.34 | Postmarket Surveillance — Sponsor or Investigator Change Records Transfer | — | View → | |
| §803.56 | 8.2.3 | Manufacturer Supplemental and Followup MDR Reports | — | View → |