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Proceedings Paper

Problems caused by regulatory delays and lack of regulation
Author(s): Lynne A. Reamer
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Paper Abstract

An FDA perspective on some of the problems encountered during the device review process is described. Emphasis is placed on the need for communication and teamwork among all parties to make the system woik. Manufacturers are encouraged to "Do it right the first time." Pertinent questions are asked of the manufacturers and proposed solutions are presented. Day to day reality at FDA is described and document workload is revealed. Lack of regulation, or more appropriately, when less regulation is appropriate is discussed. FDA has distributed to manufacturers a new draft guidance document to help in the decisionmaking process and when to submit a 510(k) when modifications are made to a device. This and other mechanisms are in place at the FDA to streamline the review process. Manufacturers are cautioned about their decisions and to seek advice from qualified persons. FDA emphasizes that help is available and that when in doubt, call.

Paper Details

Date Published: 6 December 1994
PDF: 4 pages
Proc. SPIE 2307, Health Care Technology Policy I: The Role of Technology in the Cost of Health Care, (6 December 1994); doi: 10.1117/12.195459
Show Author Affiliations
Lynne A. Reamer, Center for Devices and Radiological Health/FDA (United States)

Published in SPIE Proceedings Vol. 2307:
Health Care Technology Policy I: The Role of Technology in the Cost of Health Care
Warren S. Grundfest M.D., Editor(s)

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