Are all medical device standards covered by ASCA?

No, ASCA applies only to a specific list of FDA-recognized consensus standards and test methods deemed eligible for the program. Manufacturers must consult FDA's ASCA program website for the current scope.

Does ASCA apply to all types of medical device submissions?

While primarily impacting 510(k) submissions due to their frequent reliance on consensus standards, the principles of ASCA can contribute to efficiency in other submission types where eligible standards are applied, though the direct process benefits are most pronounced for 510(k)s.

How does a lab become ASCA-accredited?

Testing laboratories willing to participate in ASCA must apply and demonstrate their competence to an ASCA-recognized accreditation body, which assesses their conformance to ISO/IEC 17025 and other ASCA program requirements.

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Accreditation Scheme for Conformity Assessment

FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 2026

Definition

Under ASCA, FDA accepts test reports from accredited labs against eligible standards (e.g., portions of IEC 60601-1 and ISO 10993) with a presumption of conformity, reducing the likelihood of additional information requests during review. ASCA was established under the FDA Reauthorization Act of 2017 and became a permanent program in 2023. Testing labs accredited by ASCA-recognized accreditation bodies can perform testing to eligible standards, such as IEC 60601 series and ISO 10993 biocompatibility standards. When a manufacturer submits an ASCA summary test report, FDA generally does not request the underlying data unless a specific concern arises.

What the regulation says

The FDA established the Accreditation Scheme for Conformity Assessment (ASCA) program to increase efficiency in the medical device review process. The program allows for the FDA to accept test reports from ASCA-accredited testing laboratories, particularly for certain eligible standards such as parts of IEC 60601-1 and ISO 10993. This approach aims to provide a "reasonable assurance of conformity" with applicable FDA requirements, as outlined in FDA guidance documents on ASCA.

What this means in practice

Sponsors plan testing with ASCA-accredited labs to compress 510(k) review time on commonly tested standards.

Examples

A MedTech manufacturer submitting a 510(k) for an electro-medical device uses an ASCA-accredited lab for biocompatibility testing according to ISO 10993-1, significantly streamlining the biocompatibility review process.
An in vitro diagnostic company leverages an ASCA-accredited facility for electromagnetic compatibility (EMC) testing against IEC 60601-1-2, reducing the timeline for FDA's assessment of EMC data.
A company developing a new surgical tool sends its product for electrical safety testing per IEC 60601-1 to an ASCA-accredited lab, anticipating a more efficient FDA review of those specific test results.

Common pitfalls

•Misinterpreting ASCA as a blanket approval for all testing, rather than a program for specific eligible standards and tests.
•Failing to verify that the chosen laboratory is actively accredited under ASCA for the specific standard and test method required.
•Submitting ASCA-generated test reports without proper documentation or in a format not aligned with FDA guidance for ASCA submissions.
•Believing that ASCA eliminates all potential for FDA additional information requests related to testing, which is not guaranteed.
•Not understanding that ongoing surveillance and re-accreditation are part of the ASCA program for laboratories, impacting the validity of older reports.

Frequently asked questions

The primary benefit is a presumption of conformity for test reports, which typically leads to a reduced likelihood of additional information requests from the FDA during the review process for eligible devices and standards.

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Regulatory

FDA Recognized Consensus Standards

Voluntary standards that FDA has formally recognized for use in establishing device conformity.

Standards

IEC 60601-1

General requirements for basic safety and essential performance of medical electrical equipment.

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Regulatory

510(k) Premarket Notification(510(k))

FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.

Regulatory

510(k) Summary vs 510(k) Statement

Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.

Regulatory

513(g) Request for Information(513(g))

Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.

Regulatory

Abbreviated 510(k)

510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.

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Link health: 3 verified· last checked 2026-06-20

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Category: Regulatory
Acronym: ASCA
Sources: 3
Updated: 9/19/2026

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FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny.

·Sponsors plan testing with ASCA-accredited labs to compress 510(k) review time on commonly tested standards.
·ASCA was established under the FDA Reauthorization Act of 2017 and became a permanent program in 2023.
·Testing labs accredited by ASCA-recognized accreditation bodies can perform testing to eligible standards, such as IEC 60601 series and ISO 10993 biocompatibility standards.

Remember this

Watch out: Misinterpreting ASCA as a blanket approval for all testing, rather than a program for specific eligible standards and tests.

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