F2 Labs is an FDA-recognized ASCA-accredited testing laboratory, helping medical device manufacturers streamline the 510(k) submission process. Our participation in the ASCA Program ensures reliable, high-quality test data that meets FDA expectations and reduces review times.
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. To schedule testing for your product contact us or call 877-405-1580.Helpful Links:
FAQs
"For the REACH line items, looking into this it appears more for powders/mixes/chemicals than machines? We should discuss this so I have things straight.”
SALES RESPONSE:
REACH is for everything you put on EU soil, has nothing to do with CE, and is not applicable to the UK. The rules apply differently to substances, mixtures, and articles. Your equipment is a complex article (an article made of lot of other articles). An article is anything that is made with a special shape, surface, or design into something that is more defined by those attributes than by chemical composition. In other words – a piece of copper wire is an article. A piece of plastic insulation is an article. An electric cable made of copper wire and insulating wrap is a complex article.
Everything is in scope of REACH – but it applies differently to powders/mixes/chemicals (substances and mixtures) than it does to a machine (a complex article).
