All terms
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 May 5, 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. 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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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.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
FDA·1European Commission·1IMDRF·1
- 1
FDA - Medical DevicesVerifiedFDAfda.gov
- 2
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
- 3
IMDRF DocumentsVerifiedIMDRFimdrf.org
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