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FDA ASCA Pilot Program

Overview

Get FDA-recognized evaluations and test reports for your 510(k) submissions

Launched by the U.S.A. Food & Drug Administration (FDA) in September 2020, the Accreditation Scheme for Conformity Assessment (ASCA) Pilot program increases confidence in medical device testing by recognizing accredited testing laboratories. Participation in the ASCA Pilot Program is voluntary for both third party testing laboratories and medical/laboratory device manufacturers.

On April 12, 2021, CSA Group was officially announced as one of the approved testing organizations, with accredited testing laboratories in the U.S.A., Canada, China, Japan, and South Korea. As part of the ASCA Pilot program, CSA Group is able to support the FDA’s efforts to:

  • Introduce more consistency and predictability in the FDA’s approach to conformity assessments to improve the efficiency of the premarket review process
  • Decrease the likelihood of delays or questions from the FDA about testing protocols and methodologies during the review process
  • Increase confidence in the Declaration of Conformity (DOC) by using ASCA-accredited testing laboratories

Put your confidence in CSA Group for your premarket submission needs

Rely on an internationally recognized company with more than 100 years of expertise and knowledge. CSA Group has been working with medical device manufacturers for decades, providing the type of conformity test data required by the FDA. Our experts’ involvement in standards development, including standards discussions for the ASCA Pilot program, allows us to provide details about the requirements of the listed recognized standards and how they can be applied to your products.

Evolving with the industry, our services keep up with the latest advancements in medical equipment technology. We provide reliable product evaluation, testing, certification, and key supplemental services for your in-demand and innovative products. We enable manufacturers to demonstrate that their products comply with applicable safety,and performance standards for markets around the world.

How can CSA Group help with your premarket testing?

All medical device manufacturers undergoing 510(k) premarket notification to sell their medical devices in the U.S.A. market can choose to complete premarket testing through an accredited laboratory. CSA Group laboratories in the U.S.A., Canada, China, Japan, and South Korea were accredited to perform premarket testing for basic safety and essential performance of:

  • Medical equipment
  • Laboratory, test and measurement equipment

To receive ASCA accreditation, testing laboratories must meet ISO/IEC 17025 and ASCA requirements for the competence of testing laboratories. These laboratories are assessed by an ASCA-recognized accreditation body to evaluate their compliance with these requirements.
The testing laboratory is responsible for providing the information outlined in the ASCA program specifications, including:

  • ASCA summary test report
  • Detailed test report
  • Test data

View CSA Group’s accreditation scope for the ASCA Pilot program.

What are the premarket testing requirements?

CSA Group accredited laboratories recognized by the ASCA Pilot program must perform the appropriate tests according to the applicable standards of that product.

Safety Standards – Specific guidance: Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.

Standard Description
ANSI/AAMI 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (Including the FDA-recognized list of collateral and particular standards of the IEC/ISO 60601/80601 series of medical standards)
IEC 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements (along with the FDA-recognized particular standards of the IEC 61010 series of laboratory standards family)
CSA Group is accredited to perform testing as per the FDA-recognized consensus standards included in the ASCA Pilot program:
ANSI/AAMI ES60601-1 IEC 60601-2-19 IEC 60601-2-43 IEC 60601-2-35
ANSI/AAMI HA60601-1-11 IEC 60601-2-2 IEC 60601-2-44 IEC 60601-2-59
IEC 60601-1-10 IEC 60601-2-20 IEC 60601-2-45 IEC 80601-2-60
IEC 60601-1-11 IEC 60601-2-21 IEC 60601-2-47 ISO 80601-2-13
IEC 60601-1-12 IEC 60601-2-22 IEC 60601-2-5 ISO 80601-2-55
IEC 60601-1-2 IEC 60601-2-23 IEC 60601-2-50 ISO 80601-2-56
IEC 60601-1-3 IEC 60601-2-25 IEC 60601-2-52 ISO 80601-2-61
IEC 60601-1-6 IEC 60601-2-27 IEC 60601-2-54 ISO 80601-2-69
IEC 60601-1-8 IEC 60601-2-28 IEC 60601-2-62 ISO 80601-2-70
IEC 60601-2-1 IEC 60601-2-29 IEC 60601-2-63 ISO 80601-2-72
IEC 60601-2-10 IEC 60601-2-31 IEC 60601-2-64
IEC 60601-2-11 IEC 60601-2-33 IEC 60601-2-65
IEC 60601-2-16 IEC 60601-2-34 IEC 60601-2-68
IEC 60601-2-17 IEC 60601-2-36 IEC 60601-2-8
IEC 60601-2-18 IEC 60601-2-37 IEC 80601-2-30

Certifications

View accreditation certificates for each ASCA-recognized CSA Group laboratory:

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Toronto, ON, Canada

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Pointe-Claire, QC, Canada

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Richmond, BC, Canada

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Irvine, California, U.S.A.

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Shanghai, China

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Tokyo, Japan

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Seoul, South Korea

CSA Group also performs testing for many other standards, enabling different types of manufacturers to test their products and components, streamline evaluation/testing needs through one-stop service offerings, and work directly with CSA Group experienced technical experts.

View the full list of recognized consensus standards included in the ASCA Pilot Program.

 

What is the premarket testing process when using ASCA-recognized laboratories?

Step 1: A medical device manufacturer voluntarily selects an ASCA-accredited laboratory to perform testing.
Step 2: A manufacturer develops a test plan for testing at an ASCA-accredited laboratory (the lab can work with the manufacturer on the test plan development).
Step 3: The ASCA-accredited laboratory conducts the testing and provides the complete test report and the ASCA summary test report, in accordance with the ASCA Pilot program specifications.
Step 4: A manufacturer submits the required documentation to the FDA, including the DOC and the ASCA summary test report.
Step 5: The FDA reviews the submission from the manufacturer according to the specifications in the ASCA Pilot program.

 

What are the manufacturers’ responsibilities?

Medical device manufacturers using an ASCA-accredited testing laboratory are responsible for:

  • Selecting an ASCA-accredited testing laboratory to conduct testing for the FDA premarket submission
  • Developing a test plan according to the applicable standards of their product
  • Identifying any additions or modifications to test methods or acceptance criteria and special testing conditions
  • Documenting the acceptance criteria according to the risk management requirements in IEC 60601/80601 and IEC 61010 series of standards.
  • Preparing an FDA submission that includes:

Cover Letter

  • “ASCA”
  • Name(s) and location(s) of the testing laboratory(ies), ASCA Identification Number(s)
  • FDA-recognized consensus standard(s) and test methods

Declaration of Conformity (DOC)

  • DOC plus ASCA Accreditation status for the testing laboratory
  • Preparing an FDA submission that identifies the participation in the ASCA Pilot program per FDA guidance.

Supplemental Documentation

  • Additional documentation required by specific standards, such as ASCA summary test reports
  • See standards-specific ASCA Pilot guidance documents for examples

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