ARLINGTON, VA —FDA staff will discuss the agency’s latest guidance on the recognition and use of consensus standards during a newly added session at the 18th Annual Association for the Advancement of Medical Instrumentation (AAMI)/FDA International Conference on Medical Device Standards and Regulation (ISC) to be held March 19–20 in the Washington, DC, area.
Carol Herman, director of standards management in FDA’s Center for Devices and Radiological Health (CDRH), will present the session, which is intended to address numerous questions CDRH has received from industry regarding manufacturers’ attempts to demonstrate conformity with FDA-recognized consensus standards.
“The use of standards has helped to streamline the 510(k) review process as sponsors use commonly recognized protocols to test the performance and/or safety of medical devices,” says Herman. “However, because of rapidly changing technology in medical devices, standards are not ‘one-size fits all.’ Often, additional information is needed in 510(k) submissions that explain how the standards have been applied to a specific device.
FDA has developed Form 3654 to help document the use of standards and to help review staff understand how the particular standard was applied to the subject device.”
ISC provides FDA and other presenters with a prime opportunity to reach a targeted audience to address prevalent questions and concerns regarding device standards and regulation.
Another newly added session at ISC will feature a luncheon presentation from William Heetderks, MD, PhD, director of extramural science programs with the National Institute of Biomedial Imaging and Bioengineering (NIBIB) — an institute with the National Institutes of Health (NIH). He will discuss the latest efforts of NIBIB, whose mission is to improve health by leading the development and accelerating the application of biomedical technologies.
The conference will be held at the Hyatt Regency Reston, near Washington, DC’s Dulles International Airport.
For more information, including up-to-date speaker and topic information and a registration form, visit www.aami.org/ meetings/isc.
Founded
in 1967, AAMI is the world's leading organization dedicated to advancing the safe and effective development and use of medical technology. AAMI's annual conference attracts healthcare professionals from hospitals, universities, consulting firms, independent service organizations, and manufacturing companies around the world.
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