[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: 21CFR26.33]
[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
Subpart B Specific Sector Provisions for Medical Devices
Sec. 26.33 Product coverage.
(a) There are three components to this subpart each covering a
discrete range of products:
(1) Quality System Evaluations. U.S.-type surveillance/postmarket
and initial/preapproval inspection reports and European Community (EC)-
type quality system evaluation reports will be exchanged with regard to
all products regulated under both U.S. and EC law as medical devices.
(2) Product Evaluation. U.S.-type premarket (510(k)) product
evaluation reports and EC-type-testing reports will be exchanged only
with regard to those products classified under the U.S. system as Class
I/Class II-Tier 2 medical devices which are listed in Appendix B of this
subpart.
(3) Postmarket Vigilance Reports. Postmarket vigilance reports will
be exchanged with regard to all products regulated under both U.S. and
EC law as medical devices.
[[Page 255]]
(b) Additional products and procedures may be made subject to this
subpart by agreement of the parties.
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