Accreditation Scheme for Conformity Assessment of Medical Devices to Food and Drug Administration-Recognized Standards; Public Workshop; Request for Comments

概要

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Accreditation Scheme for Conformity Assessment of Medical Devices to FDA-Recognized Standards." The purpose of the workshop is to present a draft design of the Accreditation Scheme for Conformity Assessment (ASCA) pilot program. The workshop is intended to discuss and obtain input and recommendations from stakeholders on the draft accreditation scheme, including its goals and scope, a suitable framework and procedures, and requirements to facilitate implementation of an eventual pilot program. The overarching objectives of the ASCA pilot program are to streamline the standards conformity assessment of medical devices and to improve consistency and predictability in the premarket review process where certain FDA recognized standards are used.