Launched by the U.S.A. Food & Drug Administration (FDA) in September 2020, and converted into a permanent program in September 2023, the Accreditation Scheme for Conformity Assessment (ASCA) program increases confidence in medical device testing by recognizing accredited testing laboratories. Participation in the ASCA 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 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 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 program.

What are the premarket testing requirements?

CSA Group accredited laboratories recognized by the ASCA 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) Program.