F2 Labs is officially an ASCA-accredited testing laboratory that performs testing in accordance with the specifications of ISO/IEC 17025 and ASCA program specifications. We believe this program will help not only increase product safety for the end-user but also shorten the time it takes for FDA approval of your product.
What is ASCA?
The FDA launched ASCA with the intention to support its public health mission by increasing confidence in test results provided by testing laboratories. F2 Labs was among the first to become ASCA-accredited. Becoming accredited comes with standards a laboratory must follow past the initial application process, including periodic audits. This helps ensure confidence with the FDA that we are following the proper procedures and can help get your product through the FDA 510K process quicker.
According to the FDA, this program will help enhance confidence in medical device testing, promote consistency and predictability in the premarket review process, encourage effective use of FDA resources, and support international harmonization. The increased confidence in testing may be particularly helpful for premarket submissions that rely on Declarations of Conformity to FDA-recognized consensus standards using test results from ASCA-accredited testing laboratories.
Will ASCA introduce new requirements for medical device manufacturers?
No. Rather, by clearly communicating expectations for how results from ASCA-accredited testing laboratories are included and reviewed in premarket submissions, the ASCA intends to promote consistency and predictability in all of FDA’s premarket submission programs.
By virtue of a testing laboratory’s ASCA Accreditation, medical device manufacturers can be more confident early in the product development lifecycle that testing to the FDA recognized consensus standards and test methods within the laboratory’s scope of ASCA Accreditation is likely to meet FDA’s regulatory requirements. Your products will no longer be likely to be excluded from FDA approval because of an issue related to the lab’s testing if you use an ASCA Accredited lab in good standing.
FDA used elements from international conformity assessment standards in the ISO/IEC 17000 series to establish the ASCA Program. The standards within the ISO/IEC 17000 series are used worldwide by stakeholders including accreditation bodies, testing laboratories, and medical device manufacturers. In addition, most of the FDA-recognized consensus standards and test methods selected for the ASCA Program are international consensus standards. The FDA believes the experience gained in the ASCA Program could broadly inform international harmonization efforts such as standards use across jurisdictions.
ASCA is designed to increase confidence in medical device testing (by both manufacturers and consumers), which in turn will help to ensure the widespread accessibility of safe and effective medical devices.