21 C.F.R. PART 26--MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL
PART 26--MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY
Subpart A--SPECIFIC SECTOR PROVISIONS FOR PHARMACEUTICAL GOOD MANUFACTURING PRACTICES
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| Length of transition period.
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| Participation in the equivalence assessment and determination.
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| Other transition activities.
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| Equivalence determination.
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| Regulatory authorities not listed as currently equivalent.
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| Start of operational period.
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| Nature of recognition of inspection reports.
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| Transmission of postapproval inspection reports.
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| Transmission of preapproval inspection reports.
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| Monitoring continued equivalence.
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| Role and composition of the Joint Sectoral Committee.
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| Regulatory collaboration.
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| Information relating to quality aspects.
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Subpart B--SPECIFIC SECTOR PROVISIONS FOR MEDICAL DEVICES
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| Length and purpose of transition period.
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| Confidence building activities.
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| Other transition period activities.
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| Start of the operational period.
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| Exchange and endorsement of quality system evaluation reports.
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| Exchange and endorsement of product evaluation reports.
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| Transmission of quality system evaluation reports.
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| Transmission of product evaluation reports.
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| Monitoring continued equivalence.
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| Listing of additional CAB's.
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| Role and composition of the Joint Sectoral Committee.
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| Alert system and exchange of postmarket vigilance reports.
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Subpart C--''FRAMEWORK'' PROVISIONS
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| General coverage of this part.
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| Transitional arrangements.
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| Designation and listing procedures.
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| Suspension of listed conformity assessment bodies.
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| Withdrawal of listed conformity assessment bodies.
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| Monitoring of conformity assessment bodies.
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| Conformity assessment bodies.
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| Preservation of regulatory authority.
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| Suspension of recognition obligations.
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| Agreements with other countries.
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| Entry into force, amendment, and termination.
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