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Direction or inertia: the future for regulation of surgical implant devices.

Authors
Type
Published Article
Journal
Journal of clinical engineering
Publication Date
Volume
3
Issue
2
Pages
186–188
Identifiers
PMID: 10316638
Source
Medline
License
Unknown

Abstract

The time has arrived when certain standards are to be introduced to control the introduction of and appropriate use of surgical implant devices. Now is the time for the professional groups involved in standards and medical device legislation to become active and develop surgical implant device standards to be applicable for the future. A commission could be established to work with FDA in respect to the requirements for surgical implant devices. It is time for the clinical organizations involved in writing consensus standards to cooperate in the introduction of surgical implant device standards.

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