FDA ASCA Program

ASCA was established under section 707 of the FDA Reauthorization Act of 2017 (FDARA). Final guidance issued September 2020. The program lets FDA recognise Accreditation Bodies (ABs), and lets those ABs accredit testing laboratories to specific FDA-recognised consensus standards. When a manufacturer submits a 510(k) (or De Novo / PMA / IDE) containing ASCA-accredited test results, FDA accepts a brief 'ASCA Summary Test Report' in place of the deeper test data normally required, with the expectation of substantially fewer review questions on that test.

• Basic safety and essential performance — IEC 60601-1 (general), and an expanding list of -2-x particular standards.
• Electromagnetic compatibility — IEC 60601-1-2.
• Wireless coexistence — ANSI/IEEE C63.27 and AAMI TIR69.
• Biocompatibility — ISO 10993 series.
• Standards in scope are listed on the FDA ASCA program page and updated periodically.

1. FDA recognises Accreditation Bodies that meet ASCA AB requirements (built on ISO/IEC 17011 plus FDA criteria).
2. Recognised ABs accredit testing laboratories under ISO/IEC 17025:2017 plus ASCA testing-lab supplemental criteria for specific standards.
3. Accredited testing labs perform tests, issue an ASCA Declaration of Conformity to Test Method and an ASCA Summary Test Report.

• Reduced FDA review questions on tests covered by ASCA Summary Test Reports.
• Shorter average review time on substantive equivalence questions where ASCA evidence is in the file.
• Predictable test deliverable — the Summary Test Report and Declaration of Conformity to Test Method are well-defined.
• Higher confidence in the testing lab's competence to the specific standard, beyond generic ISO/IEC 17025 scope.
• Single global multi-jurisdiction testing strategy is easier — ASCA accreditation builds on ISO/IEC 17025 already used by many regulators.

• Voluntary — FDA still accepts non-ASCA test data.
• Standard-specific — accreditation is to a specific standard or family, not blanket.
• Does not relieve responsibility for safety and performance — the sponsor remains accountable for the test plan, the suitability of the standard, and the interpretation.
• Does not waive FDA's right to ask follow-up questions where the device or test setup is novel.
• ASCA evidence does not substitute for clinical evidence where clinical performance must be demonstrated.

1. Identify the FDA-recognised consensus standards applicable to the device (basic safety, EMC, biocompatibility).
2. Confirm which of those standards are in ASCA scope (FDA list is the authoritative reference).
3. Engage an ASCA-accredited testing lab for those standards. The lab is identified by its scope of accreditation, available from its AB.
4. The lab issues an ASCA Summary Test Report plus an ASCA Declaration of Conformity to Test Method, per FDA guidance.
5. Cite the ASCA materials in the submission's General Safety and Effectiveness Testing section (or equivalent in eSTAR).
6. Maintain full underlying test data on file for any FDA follow-up.

• Assuming ASCA covers every test in the submission — confirm the standard is in current ASCA scope.
• Engaging an ASCA-accredited lab whose accreditation does not include the specific standard needed.
• Filing only the Summary Test Report without the Declaration of Conformity to Test Method — both are required.
• Skipping pre-test design discussions — ASCA does not replace test plan adequacy. A Q-Sub may still be valuable for novel configurations.
• Treating ASCA as a clinical-evidence pathway — it is not.

ASCA builds on ISO/IEC 17025 testing-lab accreditation, which is internationally recognised through ILAC mutual recognition arrangements. Many ASCA-accredited labs already serve EU MDR, Health Canada, TGA Australia, and PMDA Japan submissions. Manufacturers running a unified global testing strategy gain efficiency by routing testing through ILAC-aligned ASCA labs.

ASCA is voluntary and FDA does not charge for participation. Costs are commercial — accreditation costs at the lab, testing fees per test, and the marginal effort to prepare ASCA Summary Test Reports versus standard test reports (typically lower).