Frequently Asked Questions

Are there development specifications for the ASCA program?

MedTech
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Clinical: MedTech
Guidelines & Standards

Yes, there are development specifications for the ASCA Program. The ASCA program specifications are used in addition to ISO/IEC 17025 by ASCA-recognized accreditation bodies for accreditation of testing laboratories for the ASCA Pilot.  

Specifications include: 

  • Accreditation Bodies 
  • Testing Laboratories 
  • Device Manufacturers 
  • FDA Staff