CDRH Posts New Timeline, Update on Medical Device Testing Accreditation Pilot

November 6, 2018

The FDA posted an update on its Accreditation Scheme for Conformity Assessment (ASCA) pilot, which aims to streamline conformity assessments for medical device submissions that meet yet-to-be-announced standards.

The pilot will include “a minimum of five appropriate FDA-recognized consensus standards, at least one of which will be device-specific,” according to a new ASCA Q&A web page.

The standards could include biological evaluation of medical devices and basic safety and essential performance of medical electrical equipment, medical electrical systems and laboratory equipment, according to the document.

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