FDA obstetrics-gynecology device classification report.

Abstract:

:A tentative classification of obstetrical and gynecological devices, proposed by the Panel on Review of Obstetrical and Gynecological Devices of the Bureau of Medical Devices and Diagnostic Products of the Food and Drug Administration, is presented. The devices are classified, for regulatory purposes, under 3 general categories (scientific review, specific standards, and general control) as diagnostic, surgical monitoring, prosthetic, and therapeutic devices. The development of the categoreal scheme is discussed. Comments from obstetrician-gynecologists and concerned individuals are invited.

journal_name

Am J Obstet Gynecol

authors

Thompson HE,Borders JP,Dickey RP,Freilich TH,Friedman EA,Kerr CH,Sikov MR

doi

10.1016/0002-9378(76)90054-5

subject

Has Abstract

pub_date

1976-03-15 00:00:00

pages

557-61

issue

6

eissn

0002-9378

issn

1097-6868

pii

0002-9378(76)90054-5

journal_volume

124

pub_type

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