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.

How the ASCA Pilot Functions

Under the ASCA Pilot, the FDA grants ASCA Recognition to qualified accreditation bodies to accredit testing laboratories that conduct premarket testing for medical device manufacturers. Utilizing international conformity assessment standards and a set of FDA-identified ASCA program specifications, the FDA grants ASCA Accreditation to qualified testing laboratories.

A device manufacturer may elect to use us, Compatible Electronics, an ASCA-accredited testing laboratory for FDA premarket submissions.  We can provide the device manufacturer with all the information listed in the relevant ASCA program specifications in order to conduct these tests. When a device manufacturer submits a declaration of conformity with the appropriate supplemental documentation (such as an ASCA Summary Test Report) as part of their premarket submission, the FDA will have confidence in our laboratories’ test methods and results and will not request additional information regarding testing methodologies.

These are the steps in the ASCA Pilot:

A device manufacturer may elect to use us, Compatible Electronics, an ASCA-accredited testing laboratory for FDA premarket submissions.

The 2018 guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices provides additional helpful information regarding declarations of conformity and their essential role in regulatory review.

The ASCA Pilot Includes Specifications

In accordance with the MDUFA IV commitment letter, the ASCA Pilot includes both cross-cutting (horizontal) and device-specific (vertical) standards that are of public health significance and provide or can provide the means to establish acceptance criteria.

The FDA selected standards and tests from the biocompatibility, basic safety, and essential performance series based on input from the medical device community.

Consult the ASCA Pilot Standards

Manufacturers should continue to rely on other FDA-recognized standards and provide conformance declarations in premarket submissions (see Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices); however, other standards will not be eligible for the benefits of the ASCA Pilot.

Resources

Guidance

ASCA Pilot program guidance: The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program – Final Guidance

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/basic-safety-and-essential-performance-medical-electrical-equipment-medical-electrical-systems-and

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recognition-and-withdrawal-voluntary-consensus-standards

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/biocompatibility-testing-medical-devices-standards-specific-information-accreditation-scheme

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices

• ASCA Pilot program guidance: The Accreditation Scheme for Conformity Asse https://www.fda.gov/regulatory-information/search-fda-guidance-documents/basic-safety-and-essential-performance-medical-electrical-equipment-medical-electrical-systems-andssment (ASCA) Pilot Program – Final Guidance

Phraseology

Standards recognition: The process by which the FDA identifies standards to which manufacturers of medical devices may submit a declaration of conformity to demonstrate compliance with pertinent FD&C Act provisions.

ASCA Recognition: A status granted by the FDA to accreditation bodies that demonstrate competency in accreditation activities by completing the application process outlined in the ASCA Pilot program guidance. At the time of accreditation, ASCA-recognized accreditation bodies may accredit qualified testing laboratories if FDA-recognized consensus standards and test methods fell within their scope of ASCA Recognition.

Accreditation: Third-party attestation that a conformity assessment body (such as a testing laboratory) has formally demonstrated its competence to perform specific conformity assessment tasks (refer to ISO/IEC 17000:2004 Conformance – Vocabulary and basic concepts).

ASCA Accreditation: A status given by the FDA to testing laboratories that indicate testing competency through the application process outlined in the ASCA Pilot program guidance. A testing laboratory must possess a scope of accreditation from an ASCA-recognized accreditation body in order to be eligible for ASCA Accreditation. Note that ASCA Accreditation is exclusive to the ASCA Pilot and is distinct from any accreditation that an accreditation body may grant to a testing laboratory for reasons other than the ASCA Pilot.

Suspension of ASCA Accreditation: Imposing temporary restrictions on one or more FDA-recognized consensus standards or test methods within the scope of ASCA Accreditation for a testing laboratory.

Withdrawing ASCA Accreditation: Cancelling the full scope of a testing laboratory’s ASCA Accreditation; withdrawal of ASCA Accreditation removes the organization entirely from the ASCA Pilot.

Withdrawing ASCA Recognition: Canceling the full scope of an accreditation body’s ASCA Recognition; withdrawal of ASCA Acknowledgement removes the organization from the ASCA Pilot