The FDA ASCA program, explained
What the Accreditation Scheme for Conformity Assessment is, which standards it covers and how to use ASCA test reports in your 510(k).
- Updated November 2026
- Written by an ASCA laboratory · TL-114
Overview
What ASCA is
ASCA, the Accreditation Scheme for Conformity Assessment, is an FDA program for testing to recognized consensus standards. Laboratories are accredited for specific standards. When you use an ASCA accredited laboratory within its scope, the FDA generally relies on that laboratory’s test methods and does not intend to ask you for more information about them.
The FDA launched ASCA as a pilot in September 2020. Under MDUFA V it became an ongoing program in 2023, and the FDA is preparing a final program guidance to replace the 2020 pilot guidances.
- Voluntary: you decide, standard by standard, whether to use ASCA testing.
- No extra FDA fee for manufacturers; the program is funded through MDUFA V.
- Audited: the FDA audits ASCA laboratories and can withdraw their accreditation.
- Fewer method questions: reviewers can focus on your results instead of how the test was run.
Who does what
Eligible standards
Which standards ASCA covers
ASCA covers selected FDA recognized standards in two families. The FDA adds standards over time, so always check the current list and the recognized edition for your device.
Standards in our ASCA scope · TL-114
Sigma Scientific Services tests to these 11 standards under ASCA. Editions and dates are on our accreditations page.
Standards outside the ASCA program can still be used in your submission; they just do not receive the ASCA benefits. Our A2LA ISO/IEC 17025 scope covers acoustic, imaging, optical and photobiological methods beyond ASCA.
How it works
Using ASCA in five steps
The path the FDA describes for manufacturers, from choosing standards to compiling the submission.
Your 510(k)
What goes into the submission
The documents that carry your ASCA testing into the 510(k), and when the FDA may ask for more.
Cover letter
States that the submission contains ASCA testing, and names each laboratory with its location and ASCA identification number (ours is TL-114), the standards and methods used, whether they were within the laboratory’s scope at the time of testing, and any limitations.
Declaration of conformity
One for each ASCA standard or test method. It is still the way you show conformance to an FDA recognized standard.
ASCA summary test report
Included exactly as the laboratory issued it. Keep the complete test report on file.
When the full report is needed
The FDA may still need complete test reports when the standard’s ASCA guidance recommends them or when deviations from the standard are noted.
ASCA vs. traditional
What changes in the review
| Traditional testing | ASCA testing | |
|---|---|---|
| Test methods | TraditionalReviewed by the FDA as part of your submission | ASCAAssessed in advance by the accreditation body, with FDA oversight |
| What you submit | TraditionalDeclaration of conformity and supporting test reports | ASCADeclaration of conformity and the ASCA summary test report |
| Questions on methodology | TraditionalPossible during review | ASCAGenerally not requested for testing within the laboratory’s scope |
| Your results | TraditionalReviewed by the FDA | ASCAReviewed by the FDA |
Checklist
Before you ship samples
- The edition you need is the FDA recognized edition, and it is in the laboratory’s ASCA scope.
- The laboratory’s ASCA status is active in the FDA list. The FDA has withdrawn some laboratories, and their summary reports are no longer accepted.
- Samples, accessories and configurations cover every model in the submission.
- Acceptance criteria and any allowed method changes are written into the test plan.
- You know which standards are ASCA and which will be submitted the traditional way.
- Someone on your team owns the cover letter and the declarations of conformity.
Keep reading · 6 articles
Go deeper on ASCA
A reading path from our insights: from whether your device needs ASCA to what is next for the program.
ASCA program future outlook for device teamsLikely priorities for the program, practical submission planning and how accredited testing supports FDA readiness.
Read article Reading path
- 01
What devices need ASCA testing?When the FDA may rely on accredited reports, and how to define a standards-based test plan early.
- 02
FDA ASCA eligibility: what device teams needHow eligibility shapes the way your test reports support an FDA submission.
- 03
ASCA testing versus traditional testingRecognition, scope, documentation and timing, side by side.
- 04
How to prepare an ASCA submissionEligible standards, accredited testing and FDA-ready documentation.
- 05
How long does ASCA take?Accreditation stages and timing drivers, from the laboratory side.
FAQ
ASCA questions
Is ASCA mandatory?
No. ASCA is a voluntary program. You can still submit test reports from any laboratory with a declaration of conformity; ASCA testing simply adds the program’s benefits for the eligible standards.
Does ASCA testing guarantee FDA clearance?
No. ASCA streamlines how the FDA looks at test methods. The FDA still reviews your results, your declaration of conformity and the rest of your submission.
Is there an extra FDA fee to use ASCA?
No. The FDA does not charge manufacturers an additional fee to use ASCA; the program is funded through MDUFA V. Laboratory fees for the testing itself still apply.
Can I use more than one ASCA laboratory?
Yes. Your cover letter lists each testing laboratory, its location and its ASCA identification number, together with the standards each one tested.
What if my standard is not ASCA-eligible?
You can still use it in your submission through a declaration of conformity and the supporting test report, as before. Only standards in the ASCA program receive its benefits. Our A2LA ISO/IEC 17025 scope covers many methods beyond the ASCA program.
Is ASCA only for 510(k) submissions?
The FDA describes ASCA for premarket submissions in general. The 510(k) is the most common case for the devices we test.
How do I check that a laboratory is ASCA accredited?
Use the FDA list of ASCA accredited testing laboratories and check the laboratory’s status and scope for your standard and edition. Sigma Scientific Services is laboratory TL-114. See the FDA listing.
Sources: FDA, Accreditation Scheme for Conformity Assessment · FDA, Manufacturers: How to Participate in ASCA · Federal Register notice, October 2026. Reviewed November 2026.
Plan your ASCA testing with us
Tell us about your device and the standards you need. You’ll have a quote within 24 hours.
(305) 239-4441 info@sigmascientific.us 490 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33325