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  • AAMI TIR48 : 2015

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    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    Superseded date:  21-05-2021

    Language(s):  English

    Published date:  01-01-2015

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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').

    General Product Information - (Show below) - (Hide below)

    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    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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