Retlif Receives ASCA Pilot Program Accreditation from FDA

Laboratories expand Scope of Accreditation for Medical Devices Testing

Ronkonkoma, NY, USA……A globally recognized, independent EMC/EMI and environmental testing organization, Retlif Testing Laboratories has achieved a significant milestone with FDA ASCA pilot program accreditation.

One of the first independent EMC laboratories to gain accreditation in the United States, Retlif supports conformity assessment schemes which rely on test data provided by ISO/IEC 17025 accredited laboratories. The US Food and Drug Administration (FDA) has recently embraced accreditation through a pilot program, the Accreditation Scheme for Conformity Assessment (ASCA).

ASCA incorporates international conformity assessment standards and practices with the goal of increasing confidence in medical device testing among FDA reviewers and medical device manufacturers. Anticipations are that this will decrease requests for additional information relating to testing methodologies when pre-market submissions include a declaration of conformity to an FDA-recognized consensus standard within the FDA ASCA Pilot Program.

Scopes of Accreditation include basic EMC requirements contained within IEC 60601-1-2, Edition 4.0, 2014 including requirements for medical electrical equipment and systems used in home health care and emergency medical services environments. Product testing applications range from electrocardiographs and endoscopic equipment to ultrasonic diagnostic and monitoring equipment, to x-ray equipment for computed tomography and dental intra-oral x-ray equipment among many others.

Medical equipment manufacturers can readily access this alternative path for FDA acceptance of EMC test reports from Retlif. All three Retlif EMI/EMC facilities (Harleysville PA, Goffstown NH and Ronkonkoma NY) have achieved FDA ASCA Pilot Program accreditation.

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About Retlif Testing Laboratories:

Founded in 1978 and headquartered in Ronkonkoma, New York, Retlif Testing Laboratories is one of the USA’s highest profile independent testing laboratories. Retlif provides complete EMC/EMI and Environmental Simulation Testing and engineering services for medical, aerospace and aviation, avionics, rail and transit, maritime, military, defense, and homeland security products. Retlif’s test data is recognized worldwide. The organization is strategically focused on test results with a mission to provide tangible customer value through testing and engineering services.