FDA updates on ASCA pilot, lists accredited test labs

Regulatory NewsRegulatory News | 15 April 2021 |  By 

In an important step in the rollout of its accreditation scheme for conformity assessment (ASCA) pilot, the US Food and Drug Administration (FDA) this week published its initial list of accredited testing laboratories participating in the program.
The pilot, which arose out of the negotiations for the current Medical Device User Fee Amendments (MDUFA IV) program, is meant to increase “consistency, predictability and efficiency” during the premarket review of medical devices by creating a scheme for accrediting third-party testing laboratories to eligible consensus standards. For the pilot phase of the program, FDA has selected standards that fall under two broader families of standards: biocompatibility testing and basic safety and essential performance. (RELATED: FDA finalizes ASCA pilot guidance as it gears up for launch, Regulatory Focus 24 September 2020; For 2021, CDRH plans full ASCA pilot implementation, Regulatory Focus 28 January 2021).
In total, the agency named 53 testing labs across 10 countries accredited to basic safety and essential performance standards included in the pilot. Among those accredited are laboratories from the CSA Group, Element Materials Technology, Eurofins, Intertek Testing Services, TÜV SÜD and UL. So far, no laboratories have been accredited for biocompatibility testing. For each laboratory, FDA lists the standards the lab is accredited for. The agency has also published a list of ASCA-recognized accreditation bodies tasked with accrediting the testing laboratories.
“Due to the complex nature involved in biocompatibility standards and test methods, additional review time and interaction with the applicant labs is needed,” said Simon Choi, a health science analyst in the Center for Devices and Radiological Health’s (CDRH) standards and conformity assessment program, during an industry workshop on Wednesday.
During the workshop, FDA staff involved in the ASCA pilot offered insights on the program and clarified its scope and how the program fits in with the agency’s broader standards recognition program.
“ASCA is not designed to take over the 1,400 and some recognized standards. It’s really a focused element on trying to do the biggest impact in the areas that we could based upon the type of standard that lends itself to this type of testing,” said Scott Colburn, director of CDRH’s Standards and Conformity Assessment Program (S-CAP).
Colburn explained that for now, the pilot won’t be expanded to include additional standards.
“For the purposes of the pilot, we’re not forecasting to add any new types of standard, so we’re not looking to go outside of the family of [IEC/ISO] 60601/80601 that we’ve included or expand beyond the test methods that are listed,” Colburn said, adding that the agency is interested in learning what other types of standards would lend themselves to a broader accreditation program.
Angela DeMarco, a biomedical engineer at CDRH, also noted that while the agency hopes to increase the efficiency of device reviews, the ASCA pilot is not intended to shorten review timelines.
“We’re not altering the statutory timelines for these products. What we do hope is that because we’re using ASCA accredited test labs … we hope that it will be a more efficient review process. We’re hoping that the number of questions that do get asked about the testing methodology hopefully goes down so that there’s more time for both the reviewer and the review team and the manufacturer to work out other clinical issues that may be involved with the device submission,” DeMarco said.


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