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.