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AAMI TIR48 : 2015

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

QUALITY MANAGEMENT SYSTEM (QMS) RECOMMENDATIONS ON THE APPLICATION OF THE U.S. FDAS CGMP FINAL RULE ON COMBINATION PRODUCTS
Available format(s)

Hardcopy , PDF

Superseded date

05-21-2021

Language(s)

English

Published date

01-01-2015

Glossary of equivalent standards
Committee representation
Introduction
1 Scope
2 Applying CGMPs in Accord with FDA's Final Rule
  for Combination Products (21 CFR Part 4)
3 Considerations in transitioning
  to 'Streamlined Approach'
4 Application of Design Controls and
  Management for a Combination Product
Annex A - Terminology
Bibliography

Gives recommendations on the application of CGMPs for drugs, devices, biologics, and human cells, tissues, and cellular and tissue based products during development and marketing of combination products (drug-device, biologic-device, drug-biologic, or drug-device-biologic), in accordance with the FDA's final rule (21 CFR Part 4; 78 FR 4307, 2013-hereafter 'The Rule' or 'FDA's Final Rule').

DocumentType
Standard
Pages
28
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

ISO 19011:2011 Guidelines for auditing management systems
CFR 21(PTS200-299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 200-299
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
ISO 9001:2015 Quality management systems — Requirements
CFR 21(PTS600-799) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 600-799
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO 14971:2007 Medical devices Application of risk management to medical devices

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