[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: 21CFR26.31]
[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. 26.31 Purpose.
(a) The purpose of this subpart is to specify the conditions under
which a party will accept the results of quality system-related
evaluations and inspections and premarket evaluations of the other party
with regard to medical devices as conducted by listed conformity
assessment bodies (CAB's) and to provide for other related cooperative
activities.
(b) This subpart is intended to evolve as programs and policies of
the parties evolve. The parties will review this subpart periodically,
in order to assess progress and identify potential enhancements to this
subpart as Food and Drug Administration (FDA) and European Community
(EC) policies evolve over time.
Back to Top
© 2007 Betterchem Corp.
|
