FDA ASCA Pilot Program
Simplify your FDA submittals while shortening your time to market with Intertek's FDA ASCA Pilot Program
The U.S. Food & Drug Administration (FDA) launched a new pilot program called “Accreditation Scheme for Conformity Assessment”, or “ASCA” in September of 2020. It’s a voluntary program that was developed to help increase confidence in medical device testing, therefore decreasing the need for the FDA to request additional information from manufacturers during premarket submissions.
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Under the new program, testing laboratories can apply to the FDA for ASCA Accreditation. Once approved, device manufacturers will be able to contact ASCA-accredited laboratories to begin testing. Once testing is completed, the laboratory will provide results back to the manufacturer, who can then finally make their premarket submission to the FDA.
On April 12, 2021, the FDA announced that 13 Intertek facilities around the world were officially named “ASCA-Accredited Testing Laboratories”, including 9 across the U.S., 2 in China, 1 in Italy, and 1 in Japan. No other medical device testing laboratory offers the combination of scope, reach, expertise, accreditations, and commitment to customer success that Intertek provides its customers every day.
There are two primary standards covering Basic safety and essential performance that are included in the FDA ASCA Pilot:
Standard | Standard Title |
ANSI/AAMI 60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (along with the FDA-recognized collateral and particular standards in the IEC/ISO 60601/80601 family) |
IEC 61010-1 | Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements (along with the FDA-recognized particular standards in the IEC 61010 family) |
A number of Biocompatibility standards will also be included in the FDA ASCA Pilot. Please view the ASCA page on the FDA’s website to learn more.
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