Crosswalk Library/ISO 13485 ↔ FDA 21 CFR 820
ELDR Institute · Governance Crosswalk
ISO 13485
↔
FDA 21 CFR 820

Map ISO 13485:2016 quality management system requirements to FDA 21 CFR Part 820 Quality System Regulation, enabling medical device manufacturers to maintain a single QMS satisfying both international and US regulatory documentation obligations.

Scope & Applicability

ISO 13485:2016 (clauses 4-8) mapped to FDA 21 CFR Part 820 (incorporating 2024 ISO 13485 harmonization). Applicable to medical device manufacturers seeking both ISO 13485 certification and FDA compliance across Class I, II, and III device programs.

Crosswalk Overview

The FDA's 2024 update to 21 CFR Part 820 substantially harmonized the US Quality System Regulation with ISO 13485:2016. However, the harmonization is not complete — FDA requirements in complaint handling, corrective action, and design controls retain distinct requirements. Organizations must maintain careful crosswalk documentation for areas where the frameworks diverge.

Framework 1
ISO 13485:2016
Framework 2
FDA 21 CFR Part 820 (QSR)
Related Templates
Template
Design History File Structure
Template
Risk Management File Template
Template
Medical Device Design Control Matrix
Template
FDA IFU & Labeling Template
Areas of Overlap
ISO 13485 FDA 21 CFR 820
ISO 13485 Clause 4 (QMS General)↔FDA 21 CFR 820.5 (Quality system)
ISO 13485 Clause 7.3 (Design and Development)↔FDA 21 CFR 820.30 (Design controls)
ISO 13485 Clause 8.3 (Nonconforming Product)↔FDA 21 CFR 820.90
ISO 13485 Clause 8.5.2 (Corrective Action)↔FDA 21 CFR 820.100 (CAPA)
Key Differences
Regulatory vs. Certification
ISO 13485 certification is issued by an accredited certification body. FDA 21 CFR Part 820 compliance is enforced by FDA inspection — non-compliance can result in warning letters and import bans.
Design Controls Scope
FDA 820.30 applies to Class II and III devices and some Class I. ISO 13485 Clause 7.3 applies to all devices within the certification scope.
Complaint Handling
FDA 21 CFR 820.198 requires specific complaint file and investigation documentation. ISO 13485 Clause 8.2.2 has less prescriptive investigation requirements.
FDA-Specific Requirements
FDA 21 CFR Part 820 includes Device Master Record (DMR) and Device History Record (DHR) requirements without ISO 13485 equivalents.
Post-Market Surveillance
EU MDR (often implemented alongside ISO 13485) imposes more prescriptive post-market surveillance requirements than either standard alone.
Evidence Requirements
ISO 13485 Evidence
◆Quality Manual (or equivalent per ISO 13485:2016)
◆Design History File (DHF) per Clause 7.3
◆Risk Management File (ISO 14971)
◆CAPA records (Clause 8.5.2)
◆Internal audit records (Clause 8.2.4)
◆Management review records (Clause 5.6)
◆Training records (Clause 6.2)
◆Complaint records (Clause 8.2.2)
FDA 21 CFR 820 Evidence
◆Device Master Record (DMR) per 820.181
◆Device History Record (DHR) per 820.184
◆Design History File (DHF) per 820.30(j)
◆Complaint files per 820.198
◆CAPA records per 820.100
◆Nonconforming product records per 820.90
◆Labeling controls per 820.120
Control Mapping Table

Selected high-overlap control mappings. Full crosswalk documentation available on request.

ISO 13485 Control FDA 21 CFR 820 Control
ISO 13485 4.1 (General QMS)
→
FDA 820.5 (Quality system)
ISO 13485 7.3 (Design and Development)
→
FDA 820.30 (Design controls)
ISO 13485 7.4 (Purchasing)
→
FDA 820.50 (Purchasing controls)
ISO 13485 8.2.1 (Feedback)
→
FDA 820.198 (Complaint files)
ISO 13485 8.5.2 (Corrective Action)
→
FDA 820.100 (CAPA)
ISO 13485 8.3 (Nonconforming Product)
→
FDA 820.90
Related Institute Research
ELDR-PUB-2026-009
Medical Device Documentation Standards
ELDR Advisory

Multi-framework programs
require unified documentation.

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