FDA’s ASCA pilot grows; first lab accredited for biocompatibility testing
Several months after the US Food and Drug Administration (FDA) announced the first wave of testing laboratories accredited under its accreditation scheme for conformity assessment (ASCA) pilot, the ranks of accredited labs have swelled to 68.In a first for the pilot program, the medical device-focused contract research organization NAMSA has received accreditation for biocompatibility testing. (RELATED: FDA updates on ASCA pilot, lists accredited test labs, Regulatory Focus 15 April 2021)
“Through our work with thousands of medical device manufacturers, we recognize that there are variations in test methods, parameters and report styles that can often contribute to delays in the FDA review process,” said Lisa Olson, senior vice president, global laboratory operations at NAMSA. “Based on the new ASCA requirements and guidance documents, testing disparities may now be eliminated to streamline development timelines through accurate, trusted, ASCA-accredited biocompatibility testing programs.”
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.
In the initial list of testing laboratories FDA released in April, all 53 of the labs, including CSA Group, Element Materials Technology, Eurofins, Intertek Testing Services, TÜV SÜD and UL, were accredited to basic safety and essential performance standards.
At the time, FDA officials acknowledged that accreditation to the biocompatibility standards selected for the pilot would require additional time.
“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 in April.
FDA has also updated its website for the program instructing labs interested in accreditation to biocompatibility testing standards under the program to contact the agency for a handbook that provides “greater detail on biocompatibility lab application contents.” The agency stresses that for biocompatibility applications, compliance with 21 CFR 58 Good Laboratory Practices for Nonclinical Laboratory Studies regulations for biocompatibility is required.
FDA
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