The FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program promises to smooth out the path from development to market access for device makers, but there are a few potential biocompatibility hiccups. Among these is that any customized preparation of a sample for biocompatibility testing would render that product ineligible for the ASCA pilot, but a product containing nanomaterials is also not eligible because of concerns over biocompatibility.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Medtronic recalls electrophysiology units over battery depletion; ASCA labs listed by FDA.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA lists entities recognized under ASCA program.
The U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program is intended to foster med-tech regulatory harmonization, but stakeholders saw a number of issues with the September 2019 ASCA draft guidance.
The U.S. FDA’s Accreditation Scheme for Conformity Assessment program (ASCA) seems to promise a much less burdensome approach to device performance testing, but several stakeholders have made the case that as written, the draft guidance for the ASCA pilot does little more than create another layer of review of device testing, thus defeating the point of making more extensive use of testing labs.