[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.32]

[Page 283]
 
                        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 
 
        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 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.