U.S. FDA ASCA Program - International Accreditation Service, Inc.
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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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FDA ASCA links

ASCA Pilot Guidances

 

Website Resources

ASCA Pilot Web page

www.fda.gov/medical-devices/standards-and-conformity-assessment-program/accreditation-scheme-conformity-assessment-asca

Standards & Conformity Assessment Program

www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program#intro

FDA Recognized Consensus Standards Database

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

Standards Resources

Recognition and Withdrawal of Voluntary Consensus Standards, final guidance

www.fda.gov/regulatory-information/search-fda-guidance-documents/recognition-and-withdrawal-voluntary-consensus-standards

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices, final guidance

www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices

CDRH Learn: How to Study and Market Your Device: Standards

www.fda.gov/training/cdrhlearn/default.htm

Industry Education:
Three Resources for You

CDRH Learn:  Multi-Media Industry Education

Over 200 modules

Videos, audio recordings, power point presentations, software-based “how to” modules

Mobile-friendly:  access CDRH Learn on your portable devices

www.fda.gov/CDRHLearn

Device Advice:  Text-Based Education

Comprehensive regulatory information on premarket and postmarket topics

www.fda.gov/DeviceAdvice

Division of Industry and Consumer Education (DICE)

Contact DICE if you have a question

Email:  DICE@fda.hhs.gov

Phone:  1(800) 638-2041 or (301) 796-7100 (Hours: 9 am-12:30 pm; 1 pm-4:30pm EST)

Web:  www.fda.gov/DICE

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:

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

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