[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: 21CFR26.41]
[Page 256]
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.
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