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CFR 21(PTS600-799) : 0

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

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

Superseded date

21-11-2019

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]

DocumentType
Standard
PublisherName
Code of Federal Regulations
Status
Superseded
SupersededBy

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ASTM F 2900 : 2011 Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020)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 <emph type="bdit">in vivo</emph> 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 <emph type="bdit">in vivo</emph> Evaluation in Critical Size Segmental Bone Defects
ASTM F 2884 : 2012 Standard Guide for Pre-clinical <emph type="bdit">in vivo</emph> Evaluation of Spinal Fusion (Withdrawn 2021)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 <span class="bdit">in vivo</span> 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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