FDA has cleared 53 testing laboratories to participate in its Accreditation Scheme for Conformity Assessment (ASCA) pilot, a voluntary program for medical device safety and performance testing.
The ASCA-accredited laboratories will assess whether medical devices conform to consensus standards. FDA created the program to make conformity testing more consistent for device manufacturers undergoing 510(k) premarket notification and other regulatory reviews.
So far, none of the laboratories, which include sites run by TÜV SÜD and UL, have received accreditation for biocompatibility testing. FDA plans to accredit more laboratories.
FDA finalized its guidance on ASCA last year after the release of draft documents in 2019 prompted calls for greater clarity. The finalization of the guidance positioned the agency to build a list of laboratories to put the pilot program into practice. The ASCA pilot accreditation program will allow independent testing laboratories to assess medical devices for compliance with certain FDA-recognized standards.
As of Monday, FDA had accredited 53 laboratories to assess "basic safety and essential performance" under ASCA. The laboratories have shown FDA they are accredited by an ASCA-recognized body against the basic safety standards and test methods included in the pilot.
Some companies have received accreditation for more than one laboratory. Intertek, for example, has 13 ASCA-accredited laboratories across the U.S., Asia and Europe. The 53 accredited laboratories are run by 17 companies. Thirty-seven of the laboratories are in the U.S. The other laboratories are in Canada, China, Israel, Japan, South Korea and the European Union.
UL, which has nine accredited laboratories, welcomed the pilot.
"Building in more predictability and consistency in medical device safety and performance testing and regulatory review is crucial for helping medical device companies achieve access to the U.S. healthcare market with fewer delays and lower likelihood of having to retest or provide additional information to the FDA," Pamela Gwynn, principal engineer in UL's medical device testing and conformity division, said in a statement.
FDA has yet to accredit a laboratory against biocompatibility standards. Additional laboratories will be added to the agency's list as they become accredited, according to FDA officials who spoke during Tuesday's workshop on the ASCA pilot.
Simon Choi, health science analyst in FDA's Office of Strategic Partnership and Innovation, told the workshop that "due to the complex nature of biocompatibility standards and test methods" additional review time and interaction is needed with applicant laboratories.
FDA advises medical device manufacturers to look at the scope of a laboratory's accreditation, which is detailed on the ASCA website, when deciding whether a provider is a good fit for a project.