3 Device Accreditation Guidances Issued

FDA is issuing three guidances finalizing the Accreditation Scheme for Conformity Assessment (ASCA) program. An agency Webinar on the guidances is set for 10/22, according to an online notice. The guidances are: 

•          The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program says FDA believes the voluntary ASCA pilot may further encourage international harmonization of medical device regulation because it incorporates elements, where appropriate, from a well-established set of international conformity assessment practices and standards. The voluntary pilot does not supplant or alter any other existing statutory or regulatory requirements governing the decision-making process for premarket submissions.
•          Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment—Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program to provide information on how the basic safety and essential performance standards are incorporated into the ASCA pilot; and
•          Biocompatibility Testing of Medical Devices—Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program with information on how the biological evaluation of medical devices standards are incorporated into the ASCA pilot.

The agency notice says that free online training for accreditation bodies will be held 10/29-10/30 and 11/2-11/3.