Frequently Asked Questions
Can testing performed by an ASCA-accredited testing laboratory be used to support a premarket submission?
Yes, testing performed by an ASCA-accredited testing laboratory can be used to support a premarket submission for any device, so long as the testing was conducted using an FDA-recognized consensus standard and test method eligible for inclusion in the ASCA Pilot and in accordance with the ASCA program specifications for that standard and test method.