Frequently Asked Questions

Can testing performed by an ASCA-accredited testing laboratory be used to support a premarket submission?

MedTech
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Compliance & Regulatory: MedTech

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.