[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.42]

[Page 263]
 
                        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. 26.42   Exchange and endorsement of product evaluation reports.

    (a) European Community (EC) conformity assessment bodies (CAB's) 
listed for this purpose will, subject to the specifications and 
limitations on the list, provide to FDA 510(k) premarket notification 
assessment reports prepared to U.S. medical device requirements.
    (b) U.S. CAB's will, subject to the specifications and limitations 
on the list, provide to the EC Notified Body of the manufacturer's 
choice, type examination, and verification reports prepared to EC 
medical device requirements.
    (c) Based on the determination of equivalence in light of the 
experience gained, the product evaluation reports prepared by the CAB's 
listed as equivalent will normally be endorsed by the importing party, 
except under specific and delineated circumstances. Examples of such 
circumstances include indications of material inconsistencies, 
inadequacies, or incompleteness in a product evaluation report, or other 
specific evidence of serious concern in relation to product safety, 
performance, or quality. In such cases, the importing party may request 
clarification from the exporting party which may lead to a request for a 
reevaluation. The parties will endeavor to respond to requests for 
clarification in a timely manner. Endorsement remains the responsibility 
of the importing party.