[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.