FDA staff members 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 in March.
Standards help to streamline the 510(k) review process, but rapidly changing technology in medical devices is at odds with standards that are not one-size fits all.
The session will address questions fielded by the FDA’s Center for Devices and Radiological Health from industry regarding manufacturers’ attempts to demonstrate conformity with FDA-recognized consensus standards.
The conference will be held March 19 to 20 at the Hyatt Regency Reston, near Washington, DC’s Dulles International Airport. For more information, visit AAMIs Web site.