[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: 21CFR26.42]
[Page 256-257]
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. 26.42 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
[[Page 257]]
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.
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