FDA ASCA Test Report Acceptance Package: How to Build a Bulletproof Evidence Package for 510(k) and De Novo Submissions

What This Article Covers / Does Not Cover

This article covers one specific, practical task: how to assemble the ASCA (Accreditation Scheme for Conformity Assessment) evidence package that you include in a 510(k) or De Novo submission to FDA. It walks through every component, explains what to verify before you submit, identifies the failure modes that trigger FDA questions, and gives you decision trees for handling the worst-case scenario where your testing lab loses accreditation between testing and submission.

This article does not cover how to select FDA-recognized consensus standards, how to design a test plan, how to write a 510(k) or De Novo submission from scratch, or how to interpret test results. For guidance on the broader standards landscape, see FDA Recognized Consensus Standards. For the electronic submission framework, see FDA eSTAR Electronic Submission Template.

ASCA Overview

The FDA's Accreditation Scheme for Conformity Assessment (ASCA) is a voluntary program authorized under Section 514(d) of the Federal Food, Drug, and Cosmetic Act. It streamlines the conformity assessment process by relying on FDA-accredited testing laboratories to perform testing against FDA-recognized consensus standards. The program's core promise is straightforward: when testing is performed by an ASCA-accredited lab, within the lab's ASCA scope, and the results are presented in the prescribed ASCA Summary Test Report format, FDA does not intend to question the test methods or results during the review of a 510(k), De Novo, or premarket approval submission.

ASCA is not mandatory. You can always submit complete test reports from any qualified lab. But the program offers a tangible benefit: it reduces the likelihood of Additional Information (AI) requests related to testing methodology and results, which translates to shorter review times and fewer back-and-forth cycles with FDA.

Key 2025 Program Statistics

FDA published the following data on ASCA submissions received in 2025:

One request for complete test reports out of 136 submissions. That is the program working as designed. But those 7 submissions with deficiencies are a reminder that ASCA participation alone does not guarantee a smooth review. The deficiencies arose from scope mismatches, incomplete declarations of conformity, and lab accreditation status changes -- all issues that this article will help you avoid.

What ASCA Covers

ASCA currently covers two primary testing domains:

• Biocompatibility: ISO 10993 series (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, hemocompatibility, and others)
• Basic safety and essential performance: IEC 60601 series, IEC 61010 series, and associated collateral and particular standards

In July 2025, IEC 61326-2-6 Edition 4 was fully recognized for IVD EMC testing, expanding the scope for in vitro diagnostic manufacturers using the ASCA program.

Labs participating in ASCA are accredited to ISO/IEC 17025:2017 with an ASCA-specific addendum that includes FDA-recognized standards within their scope.

ASCA Evidence Package Components

Every 510(k) or De Novo submission that leverages ASCA must include a specific set of documents. The table below details each component.

Important Notes on Components

The ASCA Summary Test Report is the linchpin. It is not the full test report. It is a condensed, standardized summary that FDA reviewers can process in approximately 30 minutes per standard. This is why ASCA reduces review time: instead of parsing a 200-page lab report, the reviewer validates a 2-page summary against the ASCA template.

The Declaration of Conformity must explicitly reference ASCA. A generic DOC that says "we conform to IEC 60601-1" is not sufficient. The ASCA DOC must state that testing was performed by an ASCA-accredited lab, identify the lab, and reference the ASCA Summary Test Report by document number.

Complete test reports are the exception, not the rule. Under ASCA, you do not normally include complete test reports in the submission. But there are specific situations where you must, and failure to understand these triggers is one of the most common failure modes.

ASCA Summary Test Report: Deep Dive

Structure and Content

The ASCA Summary Test Report follows a template provided in the applicable FDA standards-specific guidance document. The template is standardized across labs, which is the point -- FDA reviewers learn one format and apply it consistently.

A typical ASCA Summary Test Report contains:

What the Lab Provides vs. What the Manufacturer Adds

The lab provides: The ASCA Summary Test Report itself, completed on the prescribed template, with test results, standard identification, dates, and lab signature.

The manufacturer adds: Nothing to the Summary Test Report itself. The manufacturer's role is to incorporate the report into the submission package, write the Declaration of Conformity that references it, include the cover letter, and verify that all scope and accreditation elements are consistent.

This separation of responsibilities matters. The ASCA Summary Test Report is a lab document. Do not modify it, append to it, or redact information from it. If you need to provide context or explanation, put that in a separate manufacturer cover memo, not in the Summary Test Report.

Lab Accreditation Status Check: Decision Tree

Before you submit, you must verify the lab's ASCA accreditation status. This is not optional. FDA maintains a public list of ASCA-accredited laboratories, and you are responsible for confirming that the lab held valid accreditation on the date(s) testing was performed. The consequences of getting this wrong range from an AI request to a potential Refuse to Accept (RTA) determination.

Step 1: Check the current status of the lab on FDA's ASCA accredited laboratory list.

Is the lab currently listed as ASCA-accredited on FDA's website?
|
+-- YES: Proceed to Step 2 (scope verification)
|
+-- NO: Check the lab's historical status
    |
    +-- Lab status shows "Suspended"
    |   --> ASCA Summary Test Reports are NOT accepted during suspension
    |   --> You must include complete test reports regardless of when testing was done
    |
    +-- Lab status shows "Voluntarily Withdrawn"
    |   --> ASCA Summary Test Reports from dates when the lab was accredited
    |       may still be accepted -- confirm with FDA via Pre-Submission
    |   --> Prepare complete test reports as backup
    |
    +-- Lab status shows "FDA Initiated Withdrawal"
    |   --> ASCA Summary Test Reports are NOT accepted
    |   --> This occurred in September 2025 when FDA withdrew accreditation
    |       from several labs due to data integrity concerns
    |   --> You MUST include complete test reports
    |   --> FDA may request independent re-testing depending on the basis
    |       for the withdrawal
    |
    +-- Lab is not listed at all
        --> The lab was never ASCA-accredited or accreditation has expired
        --> Submit complete test reports; ASCA pathway is not available

Step 2: Confirm the accreditation was valid on the testing date(s).

Was the lab accredited on the date testing was performed?
|
+-- YES: Proceed to Step 3 (scope check)
|
+-- NO: ASCA Summary Test Report cannot be used for tests performed
|       outside the accreditation period
|   --> Submit complete test reports for those tests
|   --> If the lab was subsequently re-accredited, only tests performed
|       during the new accreditation period are eligible

Step 3: Check for status changes between testing and submission.

Has the lab's status changed since testing was completed?
|
+-- NO (lab remains accredited): Proceed with ASCA submission
|
+-- YES (status changed):
    |
    +-- Change happened BEFORE you submitted
    |   --> See "Rescue Strategies" section below
    |
    +-- Change happens AFTER you submit but BEFORE FDA decision
        --> See "Rescue Strategies" section below

Scope Matching Checklist

Even if the lab is ASCA-accredited, its accreditation scope may not cover every standard or test method you need. Scope matching is the step where most of the 7 ASCA deficiency cases in 2025 went wrong.

Scope Matching Verification Table

Use this table format to verify scope alignment before submission. Complete this internally for every standard and test method in your submission.

Pre-Submission Scope Verification Checklist

Before you contract with an ASCA lab, run through this checklist:

• Confirm the standard version you need is the same version listed in the lab's ASCA scope (version mismatches invalidate ASCA coverage)
• Confirm every test method or clause you require is explicitly listed in the lab's ASCA scope -- a lab accredited for IEC 60601-1 does not automatically cover every particular standard in the 60601 series
• Verify that the FDA-recognized edition of the standard matches the edition the lab tested against (check the FDA Recognized Consensus Standards database)
• Confirm the product code for your device is covered by the applicable standards-specific guidance
• If you are testing across multiple standards, verify the lab's ASCA scope covers all of them -- or split testing across multiple ASCA labs if needed
• Document the scope verification in your submission preparation file; this is your defense if FDA questions scope alignment

When FDA May Still Ask Questions

ASCA significantly reduces the likelihood that FDA will question your test methods and results. It does not eliminate it. FDA reserves the right to request additional information in the following situations:

The September 2025 Precedent

In September 2025, FDA initiated withdrawal of accreditation from several ASCA laboratories based on concerns about data integrity and conformance to ISO/IEC 17025 requirements. This was the first significant enforcement action in the ASCA program's history, and it established an important precedent: FDA can and will revoke accreditation when lab practices are not trustworthy, and manufacturers who relied on those labs must pivot to complete test reports.

The practical lesson: always have complete test reports available as a contingency, even when you are submitting under ASCA. Your contract with the testing lab should include a clause requiring the lab to provide complete test reports upon request, at no additional cost, within a specified timeframe.

Rescue Strategies When Lab Status Changes

Lab accreditation status can change at any point in your submission lifecycle. The strategy depends on when the change occurs relative to testing and submission.

Decision Framework

Scenario B Detail: The Most Common Difficult Situation

Scenario B is the most practically challenging. You have spent time and money on testing, the results are valid (you believe), but the lab is no longer ASCA-accredited. Here is the step-by-step response:

1. Confirm the reason for withdrawal. Contact the lab immediately. If it was FDA-initiated, obtain as much information as possible about the basis (data integrity, procedural non-conformance, etc.).

2. Obtain complete test reports. If you do not already have them, request complete test reports from the lab immediately. Your contract should provide for this.

3. Assess re-testing risk. If the withdrawal was due to data integrity concerns, the validity of your test results is in question. Consult with your regulatory team about whether re-testing at a different lab is necessary. For biocompatibility testing, re-testing may be unavoidable. For electrical safety testing, a desktop review of the complete test report by a qualified engineer may suffice.

4. Prepare the submission with complete test reports as primary evidence. The ASCA Summary Test Report becomes supplementary. Include a cover memo that transparently explains the situation.

5. Consider a Pre-Submission. If the situation is complex or novel, a Pre-Submission (Q-Submission) to FDA to discuss the approach can prevent surprises during the review.

Common Failure Modes and Remediation

ASCA vs. Non-ASCA Testing: Evidence Comparison

The table below shows what is required when you use an ASCA-accredited lab versus a non-ASCA lab for the same testing.

Source-to-Evidence Traceability Table

This table maps the full chain from the standard you are conforming to through the eSTAR section where the evidence lands. Use it as a preparation checklist to ensure nothing is lost in the handoff between your regulatory team, the testing lab, and the eSTAR template.

Fill in your actual document numbers, standard versions, and product-specific test methods before submission. The traceability chain must be unbroken: standard -> test method -> lab scope -> summary report -> DOC -> eSTAR section.

Key Takeaways

1. Verify lab accreditation status on the day of testing AND the day of submission. The September 2025 FDA-initiated withdrawals proved that status can change with serious consequences.

2. Scope matching is non-negotiable. A lab accredited for IEC 60601-1 does not automatically cover IEC 60601-1-2. Check every standard and test method individually.

3. Always have complete test reports available. ASCA is a streamlined review pathway, not an insurance policy. Complete reports are your fallback for every failure mode described in this article.

4. Use the ASCA Summary Test Report template exactly as provided. Do not modify, truncate, or reformat it. FDA reviewers expect a specific format and will flag deviations from the template.

5. The Declaration of Conformity must be ASCA-specific. A generic DOC does not activate the ASCA review pathway. Use the eSTAR built-in ASCA DOC options.

6. Proactively communicate with FDA when lab status changes mid-submission. Transparency prevents escalation. FDA has discretion in how it handles these situations, and proactive disclosure is always better than FDA discovering the issue independently.

7. ASCA and non-ASCA testing can coexist in the same submission. If your lab is ASCA-accredited for biocompatibility but not for EMC, use ASCA for biocompatibility and submit complete test reports for EMC. This hybrid approach is common and fully supported by FDA.

Sources

• FDA, "Accreditation Scheme for Conformity Assessment (ASCA)" program page and guidance documents (FDA-2020-D-0981)
• FDA, "Standards-Specific Guidance for ASCA" -- biocompatibility and basic safety/essential performance test reports
• FDA, ASCA-accredited laboratory list (updated periodically)
• Section 514(d) of the Federal Food, Drug, and Cosmetic Act
• FDA ASCA program statistics, 2025 submission data
• FDA, September 2025 enforcement actions (FDA-initiated accreditation withdrawals)
• FDA, eSTAR templates for 510(k) and De Novo submissions

Related Articles

• FDA Recognized Consensus Standards: Complete Guide
• FDA eSTAR Electronic Submission Template: Complete Guide