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Proceedings Paper

Problems caused by regulatory delays and regulation
Author(s): Glenn Pelikan
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Paper Abstract

The focus of FDA regulation on medical devices has changed substantially since its beginning in 1976. The earliest focus of GMP inspections was education of both the Industry and the Agency. Approval of new products through the 510K Premarket Notification process was generally achieved within the regulatory intended time of ninety days. Agency evaluation of 510K applications was focused on comparison to approved devices. All this has changed. The focus of GMP inspection today is enforcement. Sometimes that enforcement is targeted and sometimes it is arbitrary and capricious. Companies have been shut down and warning letters are now frequent. Some of this focus change has been warranted. Industry has been slow in its efforts to become fully GMP compliant. Approvals of 510K’s are taking much longer. The FDA’s backlog is now one year. The number of submissions has not grown substantially in the last few years, rather the process has become much slower. The amount of detail requested has, in some cases, exceeded any reasonable expectation I might have had. Current trends, if continued, represent a threat to an innovative and competitive Device Industry. Current trends are explored and changes recommended to bring about a better balance between the Agency and the Industry. The focus of FDA regulation on medical devices has changed substantially since its beginning in 1976. The earliest focus of GMP inspections was education of both the Industry and the Agency. Approval of new products through the 510K Premarket Notification process was generally achieved within the regulatory intended time of ninety days. Agency evaluation of 510K applications was focused on comparison to approved devices.

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: 10.1117/12.195460
Show Author Affiliations
Glenn Pelikan, Spacelabs (United States)


Published in SPIE Proceedings Vol. 2307:
Health Care Technology Policy I: The Role of Technology in the Cost of Health Care

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