[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.32]

[Page 254-255]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
   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--Table of Contents
 
        Subpart B_Specific Sector Provisions for Medical Devices
 
Sec.  26.32  Scope.

    (a) The provisions of this subpart shall apply to the exchange and, 
where

[[Page 255]]

appropriate, endorsement of the following types of reports from 
conformity assessment bodies (CAB's) assessed to be equivalent:
    (1) Under the U.S. system, surveillance/postmarket and initial/
preapproval inspection reports;
    (2) Under the U.S. system, premarket (510(k)) product evaluation 
reports;
    (3) Under the European Community (EC) system, quality system 
evaluation reports; and
    (4) Under the EC system, EC type examination and verification 
reports.
    (b) Appendix A of this subpart names the legislation, regulations, 
and related procedures under which:
    (1) Products are regulated as medical devices by each party;
    (2) CAB's are designated and confirmed; and
    (3) These reports are prepared.
    (c) For purposes of this subpart, equivalence means that: CAB's in 
the EC are capable of conducting product and quality systems evaluations 
against U.S. regulatory requirements in a manner equivalent to those 
conducted by FDA; and CAB's in the United States are capable of 
conducting product and quality systems evaluations against EC regulatory 
requirements in a manner equivalent to those conducted by EC CAB's.