Introduced in 2021, the Accreditation Scheme for Conformity Assessment (ASCA) program is a voluntary program that allows device manufacturers to use an ASCA-accredited testing laboratory to conduct testing to be included in premarket submissions to the FDA. The ASCA program is designed to speed up FDA review times, reduce guesswork on documentation to provide in a premarket submission, and improve the quality of testing conducted.

In September of 2023, the program was converted from a pilot to a permanent volunteer program. This blog post provides an overview of the ASCA program to help medtech companies determine if they should consider participating.  

How the ASCA program works

Under the ASCA program, the FDA grants ASCA Recognition to qualified accreditation bodies, which certifies testing laboratories to perform premarket testing for medical device companies. The FDA uses international conformity assessment standards and FDA-identified ASCA program specifications to assess ASCA Accreditation status to qualified testing laboratories.

The ASCA program includes FDA-recognized consensus standards and related test methods across two scopes:

• Biocompatibility: This scope includes standards for testing the safety of medical devices when they come into contact with human tissues.
• Basic safety and essential performance: This scope includes standards for testing the safety and performance of medical devices.
  

It’s important to note that medical device manufacturers should continue to reference additional FDA-recognized standards and provide declarations of conformity in their premarket submissions, but standards outside of biocompatibility and basic safety and essential performance are not eligible for ASCA program benefits.
‍
Medical device manufacturers can choose an ASCA-accredited laboratory to conduct its testing for FDA premarket submissions. The ASCA-accredited testing laboratory will provide the manufacturer with all information listed in the ASCA program specifications.  

For each eligible FDA-recognized consensus standard and test method, the manufacturer will need to document results on an ASCA Summary Test Report. Upon testing completion, the device manufacturer will receive an ASCA Summary Test Report from the laboratory. When the manufacturer prepares their premarket submission for FDA approval, they will need to include a declaration of conformity with the ASCA Summary Test Report as part of their submission.  

Benefits of participating in the ASCA program

Medical device companies that participate in the ASCA program can see a variety of benefits, including:  

• Faster FDA review times: The FDA has stated that it expects to review premarket submissions that include ASCA Summary Test Reports more quickly than submissions that do not.
• More clarity on documentation needed in a premarket submission: The ASCA Summary Test Report template provides a guide on what information to include in the report, which can help device manufacturers avoid having to guess what the FDA is looking for. This can save time and resources and help to ensure that the premarket submission is complete and accurate.
• Improved quality of testing conducted: ASCA-accredited testing laboratories must meet rigorous standards for competence and impartiality.
• Enhanced credibility: Participating in the ASCA program can help device manufacturers enhance their credibility with the FDA and other stakeholders. This is because the ASCA program is designed to improve the quality and efficiency of the premarket review process.

While the FDA has not announced any plans to make the ASCA program mandatory, it has stated that it intends to review premarket submissions that include an ASCA Test Summary report faster. This means that device manufacturers who participate in the ASCA program may be more likely to receive faster approvals.

In addition, some countries outside of the United States require device manufacturers to use accredited testing laboratories for premarket approval. By participating in the ASCA program, device manufacturers can demonstrate that their testing is conducted to high standards and more easily meet the requirements of these countries.

Funded through the MDUFA V User Fee program, the FDA does not charge an additional fee for manufacturers to participate in the ASCA program. For more guidance and training on the ASCA program, see the FDA’s website.  

‍