[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.33]

[Page 260]
 
                        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 REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE 
PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY--Table of Contents
 
        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.
    (b) Additional products and procedures may be made subject to this 
subpart by agreement of the parties.