More than 50 testing laboratories participating in US FDA ... | 合法醫療器材資訊網

2021年4月14日—USFDAannouncesmedicaldevicetestinglaboratoriesaccreditedunderASCAprogram.Questions?Requestmoreinformationfromourspecialists.

The US Food and Drug Administration has designated more than 50 laboratory sites to participate in the agency’s Accreditation Scheme for Conformity Assessment (ASCA) program to support more streamlined regulatory reviews of medical device market applicants’ compliance to voluntary consensus standards.

FDA’s initial list[1] of ASCA-accredited laboratories includes 53 sites run by several companies, including UL, CSA Group, Dekra, Eurofins and Intertek.

Support for streamlined medical device safety and performance testing

All sites listed are designated to perform basic safety and essential performance testing to ANSI/AAMI 60601-1 as well as IEC 61010-1 standards for medical devices undergoing FDA 510(k) and other premarket submissions. Testing to biocompatibility standards such as ISO 10993 is also included in the ASCA program, but no laboratories currently on the FDA list of p...

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More than 50 testing laboratories participating in US FDA ... | 合法醫療器材資訊網

2021年4月14日 — US FDA announces medical device testing laboratories accredited under ASCA program. Questions? Request more information from our specialists. Read More

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