FDA ASCA Pilot

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.

FDA ASCA Pilot program for Test Labs

 

Test Plan Development and a Test Lab’s role in interacting with Manufacturers

The manufacturers are ultimately responsible for the test plan and the appropriate selection and use of recognized consensus standards ie., ISO 13485 Quality Management Systems and ISO 14971 Risk Management. However, through ASCA, test labs are able, to have a more active role in developing the plan. The test plan will have guidance from 60601-1, 60601-1-2 and any published guidance documents from the FDA.  As the ASCA labs often have more expertise and experience with these standards and their application, test labs can provide the manufacturer with feedback and assist in the development of the test plan. The goal is a collaborative effort, whereas prior to ASCA, the manufacturers typically dictated the test plan.

If the test lab has questions with aspects of the test plan, the test lab can send a request in the ASCA summary test plan report to receive additional guidance from the FDA which helps streamline the testing requirements that will be part of the 510K submittal or letter to file FDA path.

Essential Performance

As we all know, essential performance is a complicated topic and often causes confusion.

Occasionally, FDA sees test reports (outside of ASCA) with essential performances that don’t make sense (i.e., an essential performance listed in the test report as “remote controller”). If the test lab has questions about the essential performances identified they can request additional guidance which prevents further question by the FDA.

Please note: The FDA does not require all normative references in our FDA-recognized standards to be FDA-recognized (in this case, the use of IEC 60601-1 ed. 3.2 for these collaterals). The ASCA Pilot differs from other conformity assessment schemes in this way (e.g., the CB Scheme).From a practical ASCA-participation perspective, if manufacturers and test labs develop a test plan which includes the 2020 editions of the collaterals as well as ANSI/AAMI ES60601-1 (as included in the ASCA Pilot), FDA would expect the Summary Test Report for 60601-1 to highlight any specific deviations from the recognized standard (in this case, in order to comply with IEC 60601-1 ed 3.2 amended clauses included in the 2020 collaterals) including any explanation for the utilization of the updated clauses. For instance, we understand that many of the amended clauses in IEC 60601-1 ed. 3.2 could improve the safety of a device. Highlighting this would be beneficial for FDA’s review of these Summary Test Reports and would be appropriate use of the standards, despite the lack of recognition of the IEC 60601-1 ed. 3.2.

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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