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Demystifying FDA’s ASCA on Biocompatibility for Expedited Review

Live from MD&M BIOMEDigital: Medical device manufacturers can potentially speed review by testing to recognized standards performed at accredited labs.

Could FDA's ASCA program save submission time and boost pre-market testing consistency in the medical device industry?
Could FDA's ASCA program save submission time and boost pre-market testing consistency in the medical device industry?

A 2020 FDA guidance may soon help boost consistency in medical device testing and expedite review of submissions for eligible devices.

At MD&M BIOMEDigital, Chris Parker, head of in-vivo biocompatibility at Toxikon, explained that in Sept. 2020, FDA published final guidance on Accreditation Scheme for Conformity Assessment (ASCA), launching a program where labs that perform testing for ISO 10993—Biocompatibility and IEC 61010/IEC 60601–Basic Safety and Essential Performance can become accredited by the FDA.

The key ASCA takeaway for manufacturers is that the testing performed to recognized standards at these accredited labs may be submitted with only a summary report instead of a full report (if no unexpected results occur) and they can expect an expedited review during submission.

Parker explained that this effort began as a pilot program, advancing to FDA guidance documents in Sept. 2020:

In early 2021, the first wave of accredited bodies (ABs) was published, and it is projected that in Apr. 2021, the first wave of FDA-approved labs will be posted. This depends on timelines for ABs as they can become quite busy.

Participation is voluntary, and it revolves not just around the technical standards, but quality systems as well.

Chris Parker explained that the ASCA program revolves not just around the technical standards, but quality systems as well. (Credit: Toxikon)Chris Parker explained that the ASCA program revolves not just around the technical standards, but quality systems as well. (Credit: Toxikon)

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