FDA Accreditation Scheme for Conformity Assessment (ASCA)

ASCA Pilot Program Participation

Compatible Electronics, Inc. is a testing laboratory participant under the United States Food and Drug Administration’s Accreditation Scheme for Conformity Assessment (FDA ASCA) pilot program. We are listed under ASCA ID# TL-80, TL-81 and TL-82.

Please see the FDA ASCA-Accredited Testing Laboratories listing page

ASCA-Accredited testing laboratories are ISO/IEC 17025 accredited testing laboratories with the inclusion of the FDA ASCA program specifications associated to ASCA eligible standards and test methods within their scope and listed by the FDA as a qualified testing laboratory participant in the ASCA Pilot program. Such laboratories are eligible to label their testing as having been conducted under the ASCA Pilot for FDA-recognized consensus standards and submit an ASCA summary report.

ASCA summary test reports

ASCA summary test reports are reports that will be included in a manufacturer’s premarket submission to the FDA, together with a manufacturer’s Declaration of Conformity (DOC). This summary report decreases the need for the FDA to request additional information regarding testing methodologies as the laboratory has been appropriately assessed by a competent accreditation body.

Enhanced confidence in test results
The ASCA Pilot processes and policies are designed to support the FDA’s public health mission by providing enhanced confidence in testing results from ASC-accredited testing laboratories.

The ASCA program specifications provide expectations for the accreditation of testing laboratories for basic safety and essential performance of medical electrical equipment, medical electrical systems, and laboratory medical equipment under the ASCA Pilot Program.

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