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U.S. FDA ASCA Program

U.S. FDA ASCA

ISO/IEC Standard 17025


The U.S. Food and Drug Administration (FDA) has recognized IAS under the Accreditation Scheme for Conformity Assessment (ASCA) pilot program to accredit testing laboratories that perform premarket testing for medical device companies. In this program, IAS will accredit testing laboratories using the standard ISO/IEC 17025 and the ASCA program specifications.

Relying upon international conformity assessment standards and a set of FDA-identified ASCA program specifications, the pilot is intended to increase consistency and predictability in the FDA’s approach to assessing conformance with FDA-recognized consensus standards and test methods eligible for inclusion in the ASCA Pilot in medical device premarket reviews. Ultimately, the ASCA Pilot is intended to help the FDA ensure patients have timely and continued access to safe, effective, and high-quality medical devices.

FDA ASCA Process

The first step in the process is to obtain accreditation from an ASCA-recognized accreditation body (i.e. IAS), which includes an assessment to ISO/IEC 17025 and the ASCA Pilot program specifications. For laboratories already accredited by IAS to ISO/IEC 17025, the process involves a scope expansion by IAS to include the ASCA program specifications. The next step involves the laboratory submittal of an application for ASCA Accreditation to the FDA.

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Deadlines for Application and Participation

The FDA will publish the initial list of ASCA-accredited testing laboratories by April 12, 2021. To be included in the initial list, laboratories must adhere to the following deadlines:

IAS assessments of laboratories need to be completed by January 22, 2021.

Testing laboratories that would like to be considered for the initial list of ASCA-accredited testing laboratories should submit their applications for ASCA Accreditation to FDA no later than February 9, 2021. The FDA will update this list throughout the Pilot as additional testing laboratories receive ASCA Accreditation.

The FDA intends to publish the initial list of ASCA-accredited testing laboratories by April 12, 2021. The initial list will be updated throughout the Pilot as additional testing laboratories receive ASCA Accreditation.

IAS’ scope of ASCA Recognition to the FDA-recognized
consensus standards and test methods included in the ASCA Pilot are listed below.

Biocompatibility Testing of Medical Devices

  • ISO 10993-4 Complement Activation using a U.S. marketed ELISA kit
  • ISO 10993-4 and ASTM F756 Direct and Indirect Hemolysis
  • ISO 10993-5 MEM Elution Cytotoxicity
  • ISO 10993-10 Dermal Irritation, Intracutaneous Reactivity Irritation, and Closed Patch Sensitization
  • ISO 10993-10 and ASTM F720 Guinea Pig Maximization Sensitization
  • ISO 10993-11 Acute Systemic Toxicity
  • ISO 10993-11 and USP 151 Material-Mediated Pyrogenicity
  • ISO 10993-12 Sample preparation for all test types

Basic Safety and Essential Performance

ANSI/AAMI ES60601-1 IEC 60601-2-11 IEC 60601-2-36 ISO 80601-2-12
IEC 61010-1 IEC 60601-2-16 IEC 60601-2-37 ISO 80601-2-13
IEC 60601-1-2 IEC 60601-2-17 IEC 60601-2-43 IEC 80601-2-30
IEC 60601-1-3 IEC 60601-2-18 IEC 60601-2-44 IEC 80601-2-35
IEC 60601-1-6 IEC 60601-2-19 IEC 60601-2-45 ISO 80601-2-55
IEC 60601-1-8 IEC 60601-2-20 IEC 60601-2-47 ISO 80601-2-56
IEC 60601-1-10 IEC 60601-2-21 IEC 60601-2-50 IEC 80601-2-59
IEC 60601-1-11 IEC 60601-2-22 IEC 60601-2-52 IEC 80601-2-60
ANSI/AAMI HA60601-1-11 IEC 60601-2-23 IEC 60601-2-54 ISO 80601-2-61
IEC 60601-1-12 IEC 60601-2-25 IEC 60601-2-57 ISO 80601-2-69
IEC 60601-2-1 IEC 60601-2-27 IEC 60601-2-62 ISO 80601-2-70
IEC 60601-2-2 IEC 60601-2-28 IEC 60601-2-63 ISO 80601-2-72
IEC 60601-2-5 IEC 60601-2-29 IEC 60601-2-64 ISO 80601-2-74
IEC 60601-2-6 IEC 60601-2-31 IEC 60601-2-65 IEC 80601-2-77
IEC 60601-2-8 IEC 60601-2-33 IEC 60601-2-68 ISO 80601-2-79
IEC 60601-2-10 IEC 60601-2-34 IEC/TR IEC 60601-4-2 ISO 80601-2-80

 

Contact Information

To convey your laboratories’ interest in the program to IAS, please email:

Get A Quote!

To receive a quote for accreditation, please visit the IAS Customer Portal.

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