[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.32]
[Page 254]
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.
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