Understanding the FDA's ASCA Program

01 Oct 2024

Key Insights and FAQs

The U.S. Food and Drug Administration's (FDA) Accreditation Scheme for Conformity Assessment (ASCA) program has generated significant interest within the medical device industry. While it remains voluntary, the ASCA program offers manufacturers a streamlined pathway for ensuring compliance with certain regulatory standards. During our recent webinar on this topic, we had the privilege of being joined by Eric Franca, the ASCA team lead at the FDA, where he shared several key program updates with attendees. He also answered a number of questions, some of the most common of which we explore below.

Will the ASCA Program become Mandatory?

According to the FDA, there are currently no plans to make ASCA a mandatory program. It is now a permanent, yet voluntary, program under the legislative framework provided by section 514 of the Food, Drug, and Cosmetic Act (FD&C Act). This means that while the FDA encourages the use of standards within the Center for Devices and Radiological Health (CDRH), their use remains entirely voluntary unless explicitly required by regulation.

Is it Necessary to Test All Standards under ASCA?

Manufacturers have flexibility when it comes to submitting test reports under the ASCA program. A combination of ASCA and non-ASCA accredited test reports can be used in your premarket submissions. For instance, a manufacturer might use one ASCA-accredited lab for general standards testing and another for electromagnetic compatibility (EMC) testing. Importantly, the ASCA Summary Test Report must come from the lab that conducted the testing, and this report should be submitted as-is to support your premarket submission.

What if Required Standards are not Covered by ASCA?

The ASCA program does not cover all standards, but this does not prevent manufacturers from participating in the program. You can still submit test results for standards not included in the ASCA program alongside your ASCA Summary Test Reports in a premarket submission. This flexible approach allows manufacturers to leverage the benefits of the ASCA program without being limited by its current scope.

Are There Additional Fees for Participating in ASCA?

The ASCA program operates under the Medical Device User Fee Amendments (MDUFA), meaning it is funded by user fees already paid by manufacturers. There are no additional fees specifically for participating in the ASCA program.

Does ASCA Add Time to the Evaluation Process?

While there may be some additional time required to generate the ASCA Summary Test Report, this does not significantly impact the overall assessment time. The harmonization of standards like the 60601-1 and 61010-1 Series helps streamline the process, ensuring that the testing plan meets FDA expectations efficiently.

Can ASCA be Used for Submissions Beyond 510(k)?

In short, yes. Manufacturers have successfully used ASCA for various submission types, including De Novos, Investigational Device Exemptions (IDEs), and Premarket Approval (PMA) applications. However, it is currently not permitted for third-party submissions.

How Should Deviations in Test Reports be Handled?

Deviations are handled differently depending on the type of testing—whether for biocompatibility or basic safety. It is essential to distinguish between modifications (which may be permissible under certain circumstances) and deviations. For biocompatibility testing, specific instructions on handling deviations can be found in the ASCA Biocompatibility Guidance document. The FDA encourages manufacturers to consult directly with them if there are any questions.

Can ASCA Summary Test Reports be Updated?

Yes, manufacturers can update their ASCA Summary Test Reports if necessary. Any updates should be clearly documented, with explanations provided for any changes made. This transparency helps ensure that the FDA fully understands the context and reasons behind any modifications.

Are Comments on ASCA Reports Handled Differently?

Comments or deficiencies from the FDA are handled in the same manner as they would be for non-ASCA submissions. The ASCA program, however, tends to result in fewer questions and deficiencies due to its rigorous standards.

Can Manufacturers Obtain ASCA Accreditation for their Labs?

Yes, manufacturers with in-house testing facilities can seek ASCA accreditation. The first step is to ensure that the lab is accredited to ISO/IEC 17025 and meets additional ASCA-specific requirements. Working with an ASCA-recognized accreditation body can help guide this process, which may be particularly beneficial for companies with frequent FDA submissions.

The ASCA program provides a valuable framework for manufacturers seeking to streamline their regulatory submissions, though it remains a voluntary initiative. Understanding how to navigate this program can help ensure a smoother path to market for medical devices.