CFR 21(PTS600-799) : 0

Superseded

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FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 600-799

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Superseded date: 21-11-2019

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Published date:

Publisher: Code of Federal Regulations

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

Part 600 - Biological products: general
Part 601 - Licensing
Part 606 - Current good manufacturing practice for blood and blood
           components
Part 607 - Establishment registration and product listing for
           manufacturers of human blood and blood products
Part 610 - General biological products standards
Part 630 - General requirements for blood, blood components, and
           blood derivatives
Part 640 - Additional standards for human blood and blood products
Part 660 - Additional standards for diagnostic substances for
           laboratory tests
Part 680 - Additional standards for miscellaneous products
Part 700 - General
Part 701 - Cosmetic labeling
Part 710 - Voluntary registration of cosmetic product establishments
Part 720 - Voluntary filing of cosmetic product ingredient composition
           statements
Part 740 - Cosmetic product warning statements
Part 741-799 - [Reserved]

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Document Type	Standard
ISBN
Pages
Published
Publisher	Code of Federal Regulations
Status	Superseded
Superseded By	CFR 21(PTS600-799) : 2019

Standards Referenced By This Book - (Show below) - (Hide below)

DI-TCSP-82040 Base Document:2016	RESEARCH AND DEVELOPMENT OF MEDICAL PRODUCTS REGULATED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA)
CGSB 106.5 : 95 CORR 1 95	BLOOD GROUPING AND ANTI-HUMAN GLOBULIN REAGENTS
ASTM F 2900 : 2011	Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020)
ANSI/AAMI/IEC 60601-1-2:2014	MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
ASTM F 2529 : 2013	Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
ASTM F 2027 : 2016 : REDLINE	Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
ASTM F 2721 : 2009 : R2014	Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
ASTM F 2884 : 2012	Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion (Withdrawn 2021)
ASTM F 2386 : 2004	Standard Guide for Preservation of Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013)
ASTM F 2383 : 2011 : REDLINE	Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)
ISO/TR 18112:2006	Clinical laboratory testing and in vitro diagnostic test systems In vitro diagnostic medical devices for professional use Summary of regulatory requirements for information supplied by the manufacturer
AAMI TIR48 : 2015	QUALITY MANAGEMENT SYSTEM (QMS) RECOMMENDATIONS ON THE APPLICATION OF THE U.S. FDAS CGMP FINAL RULE ON COMBINATION PRODUCTS
NFPA 921 : 2017	GUIDE FOR FIRE AND EXPLOSION INVESTIGATIONS
ASTM F 2903 : 2011	Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020)
ASTM F 963 : 2017 : REDLINE	Standard Consumer Safety Specification for Toy Safety
ASTM F 2721 : 2009	Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
IEC 60601-1-2:2007	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

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