The FDA’s ASCA Program

Big news in the product compliance world is the FDA’s new ASCA program. The FDA has launched ASCA with the intention to support its public health mission by increasing confidence in test results provided by testing laboratories. Testing laboratories apply to become ASCA-accredited. This is the first time in history that the FDA has had a list of approved labs. Becoming accredited comes with standards a laboratory must follow past the initial application process, including periodic audits that can result in suspension or withdraw of accreditation.  

The FDA hopes 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.

ASCA does not introduce new requirements for medical device manufacturers. 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 the FDA’s premarket submission programs.

By virtue of a testing laboratory’s ASCA Accreditation, 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.

FDA used elements from international conformity assessment standards in the ISO/IEC 17000 series to establish the ASCA Pilot. The standards within the ISO/IEC 17000 series are used worldwide by stakeholders including accreditation bodies, testing laboratories, and device manufacturers. In addition, most of the FDA-recognized consensus standards and test methods selected for the ASCA Pilot are international consensus standards. FDA believes the experience gained in the ASCA Pilot 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.

F2 Labs is officially an ASCA-accredited testing laboratory that performs testing in accordance with the specifications of ISO/IEC 17025 and FDA 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. Let F2 Labs provide you with the testing you need to get through the FDA approval process.

For more info from the FDA about the ASCA program, click here.

To schedule testing for your product contact us or call 877-405-1580.

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