[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.41]

[Page 285]
 
                        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. 26.41   Exchange and endorsement of quality system evaluation reports.

    (a) Listed European Community (EC) conformity assessment bodies 
(CAB's) will provide FDA with reports of quality system evaluations, as 
follows:
    (1) For preapproval quality system evaluations, EC CAB's will 
provide full reports; and
    (2) For surveillance quality system evaluations, EC CAB's will 
provide abbreviated reports.
    (b) Listed U.S. CAB's will provide to the EC Notified Body of the 
manufacturer's choice:
    (1) Full reports of initial quality system evaluations;
    (2) Abbreviated reports of quality systems surveillance audits.
    (c) If the abbreviated reports do not provide sufficient 
information, the importing party may request additional clarification 
from the CAB.
    (d) Based on the determination of equivalence in light of the 
experience gained, the quality system 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 or 
inadequacies in a report, quality defects identified in postmarket 
surveillance or other specific evidence of serious concern in relation 
to product quality or consumer safety. In such cases, the importing 
party may request clarification from the exporting party which may lead 
to a request for reinspection. The parties will endeavor to respond to 
requests for clarification in a timely manner. Where divergence is not 
clarified in this process, the importing party may carry out the quality 
system evaluation.