IVD Technology Magazine | IVDT Article Index
Originally published March, 1997
Editor's Page
Communicating best practices
In a regulated industry, nothing influences the outlook of companies and their investors quite as much as regulatory policy and the performance of the regulatory agency. By those measures, device and diagnostics manufacturers may have reason for optimism during the current year.
According to the FY 1996 annual report of FDA's Office of Device Evaluation (ODE), agency performance continues to be on the upswing. Posted last month on the device center's web site (http://www.fda.gov/cdrh), the report indicates that ODE has made considerable progress in doing away with the backlog of product submissions that once lingered there. In fact, as of September 30, 1996, the device center's backlog of 510(k) notifications stood at zero.
Previewing the report last month at the Medical Device Executive Forum in Anaheim, California, ODE director Susan Alpert expressed satisfaction with the current trend, but promised further efforts toward improvement. This year, she said, the center would be concentrating its energies on "reinventing its goals and processes, involving constituencies, and identifying best practices."
One such best practice highlighted by Alpert is ODE's new ability to accept electronic product submissions. Recently installed computers and videoconferencing equipment, she said, "will help to bring the office and all of its divisions rapidly into the 21st century." Just how far the agency has come can be seen in this issue's article by Janice Kates et al. (page 36), which describes the authors' experience in filing the first electronic submission handled by ODE's Division of Clinical Laboratory Devices.
But sometimes even the most advanced technologies have to take a back seat. Take, for example, the recent revision of FDA's In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions. Approved for distribution last January, the new manual incorporates regulatory changes made since the first edition of the manual (1987), and includes sections on current IVD classifications, device modifications, the "truthful and accurate" statement, and indications for use. Extensive appendixes cover exempt IVDs, triage review procedures, and third-party review of submissions.
Agency experts don't expect this manual to be posted on the center's web site for some time. But manufacturers can order printed copies now by contacting Kim Askew, product fulfillment coordinator, at Canon Communications, 310/392-5509. All of which confirms that even on the near side of cyberspace, providing up-to-date and useful information will always be considered a best practice.
Steven Halasey
steve.halasey@cancom.com
