Accreditation Scheme for Conformity Assessment (ASCA)

by Nikita Angane | Apr 19, 2021 | FDA, Medical Devices, Pharmaceuticals, Regulatory

man and woman scientists in lab coats look into a beaker as another male scientist looks into a microscope

FDA launched the ASCA Pilot on September 25, 2020. This pilot would grant ASCA recognition to qualified accreditation bodies to accredit testing laboratories to conduct pre-market testing on medical device companies and their devices.¹

The pilot is based on internationally recognized conformity assessment standards and certain FDA-identified specifications. The pilot aims to harmonize the conformance assessment of FDA-recognized consensus standards and test methods to be included in the medical device pre-market reviews.¹

This will potentially reduce the burden of reviewing individual pre-market submissions where test reports are submitted from accredited laboratories as well as incorporate internationally recognized assessment standards. This will in turn reduce the review times for pre-market submissions as it would decrease the need for FDA to request additional information about the test methods utilized.¹

Testing laboratories can apply for ASCA accreditation in a two-step process where the laboratory is assessed against ISO 17025:2017 requirements and the ASCA pilot-specific requirements.¹

FDA has designated more than 50 laboratories to participate in this pilot program. You can find the list here.

Device manufacturers may voluntarily use an ASCA-accredited testing laboratory to conduct testing that will be included in their pre-market submissions. A device manufacturer using an ASCA-accredited testing laboratory under the ASCA Pilot can include a declaration of conformity for the test conducted.¹

This effort by the FDA is in line with the practice followed in the EU as it pertains to third-party conformity assessments. I believe that this program has huge potential to reduce the review period of pre-market submissions by the FDA and thus help companies save time and money in the long run.

EMMA International can assist you with all your compliance needs. Call us today at 248-987-4497 or email us at info@emmainternational.com

¹FDA (2021)Accreditation Scheme for Conformity Assessment (ASCA) retrieved on 04/14/2021 from https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/asca-accredited-testing-laboratories?utm_medium=email&utm_source=govdelivery

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.