Problems caused by regulatory delays and lack of regulation

Lynne A. Reamer

doi:10.1117/12.195459

6 December 1994 Problems caused by regulatory delays and lack of regulation

Lynne A. Reamer

Proceedings Volume 2307, Health Care Technology Policy I: The Role of Technology in the Cost of Health Care; (1994) https://doi.org/10.1117/12.195459
Event: The Role of Technology in the Cost of Health Care, 1994, Arlington, VA, United States

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 FDA has distributed to manufacturers a new draft guidance document to help in the decisionmaking process and when to submit a 510(k) when modifications are made to a device.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.

Citation Download Citation

Lynne A. Reamer "Problems caused by regulatory delays and lack of regulation", Proc. SPIE 2307, Health Care Technology Policy I: The Role of Technology in the Cost of Health Care, (6 December 1994); https://doi.org/10.1117/12.195459

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