AAMI TIR102-2019 PDF

Full title and description

AAMI TIR102:2019 — U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems. This Technical Information Report provides a clause-by-clause mapping and cross-reference tool to help U.S. medical device manufacturers, quality and regulatory professionals, and auditors identify which U.S. Food and Drug Administration (FDA) 21 CFR regulatory requirements correspond to the "regulatory requirements" references in ISO 13485:2016, facilitating application of an ISO 13485 QMS in the U.S. regulatory context.

Abstract

The report presents a systematic mapping between FDA requirements (primarily those found in 21 CFR, including the Quality System Regulation/related requirements) and the regulatory-requirement references embedded in ISO 13485:2016. It includes tables and narrative guidance intended to make clear where U.S. legal/regulatory obligations align with or differ from ISO 13485 clauses, enabling organizations to address U.S. regulatory expectations through their ISO 13485-based QMS.

General information

• Status: Active (Technical Information Report published by AAMI).
• Publication date: 30 August 2019.
• Publisher: Association for the Advancement of Medical Instrumentation (AAMI).
• ICS / categories: Management systems and quality management for medical devices (typical ICS codes used for ISO 13485 content: 03.100.70; 03.120.10; 11.040.01).
• Edition / version: TIR102:2019 (first published 2019).
• Number of pages: 146.

Scope

Defines and documents the relationship between U.S. FDA statutory/regulatory requirements in Title 21 CFR (including quality system and other device-related requirements) and the "regulatory requirements" references called out throughout ISO 13485:2016. The report is intended as a practical cross-reference for applying ISO 13485 in a U.S. regulatory environment and for identifying potential gaps or additional controls needed to satisfy U.S. law.

Key topics and requirements

• Clause-by-clause mapping of ISO 13485:2016 to relevant 21 CFR provisions (including core QMS/820 topics such as design controls, production and process controls, CAPA, complaint handling, records and documentation).
• Cross-reference tables and narrative explanations showing where ISO 13485 addresses (or does not directly address) specific U.S. regulatory requirements.
• Guidance for interpreting the phrase "regulatory requirements" in ISO 13485 when implementing an ISO-based QMS for the U.S. market.
• Notes on responsibilities, records, and documentation practices needed to demonstrate compliance with U.S. regulations when using ISO 13485 as the QMS framework.
• References to related guidance and normative documents used in the mapping.

Typical use and users

Primary users include regulatory affairs and quality assurance professionals at medical device manufacturers, contract manufacturers and device subcontractors, auditors and certification bodies, regulatory consultants, and compliance teams seeking to align an ISO 13485-based QMS with U.S. FDA requirements. The TIR is used during QMS implementation, gap analyses, internal audits, regulatory strategy development, and training.

Related standards

Key related documents include ISO 13485:2016 (Medical devices — Quality management systems — Requirements for regulatory purposes), ANSI/AAMI/ISO 13485 adoptions, FDA regulations in 21 CFR (QSR/QMSR and related parts), ISO 14971 (risk management), and other AAMI TIRs and guidance documents addressing quality systems and regulatory interpretation.

Keywords

ISO 13485, 21 CFR, FDA, Quality Management System, QMS, mapping, regulatory requirements, AAMI, TIR102, design controls, CAPA, complaint handling, medical device compliance.

FAQ

Q: What is this standard?

A: AAMI TIR102:2019 is a Technical Information Report that maps U.S. FDA regulatory requirements (21 CFR) to the "regulatory requirement" references cited in ISO 13485:2016, providing a cross-reference and explanatory resource for implementing an ISO 13485-based QMS in the United States.

Q: What does it cover?

A: It covers clause-level cross-references, tables, and narrative guidance showing how specific provisions of U.S. federal regulations align with or relate to clauses in ISO 13485:2016, with emphasis on quality system elements such as design controls, production controls, corrective and preventive action (CAPA), complaint handling, documentation and records.

Q: Who typically uses it?

A: Regulatory affairs and quality professionals at medical device manufacturers and suppliers, auditors, conformity assessment bodies, and consultants who need to reconcile ISO 13485 requirements with U.S. regulatory obligations.

Q: Is it current or superseded?

A: The report was published in 2019 and remains an AAMI-published Technical Information Report. It is a guidance/mapping tool (not a normative regulation) and should be used together with the current text of ISO 13485 and the applicable U.S. regulations; users should verify whether more recent regulatory changes affect specific mappings or interpretations. (See current FDA guidance and regulatory updates for the most recent legal requirements.)

Q: Is it part of a series?

A: Yes — it is one item in AAMI's Technical Information Report (TIR) series and is related to other AAMI guidance and TIR documents addressing quality systems, ISO 13485 application, and regulatory topics.

Q: What are the key keywords?

A: ISO 13485, 21 CFR, FDA, QMS, regulatory mapping, AAMI, design controls, CAPA, medical devices.