FDA ASCA Program Explained
The FDA's Accreditation Scheme for Conformity Assessment (ASCA) pre-qualifies testing laboratories so that their test reports are accepted by FDA without routine review. For medical device manufacturers, using an ASCA-recognized laboratory can significantly accelerate 510(k) clearance and reduce the risk of test-related delays.
ASCA Recognized LabTL-80 TL-81 TL-82510(k) AccelerationNVLAP Accredited
What is ASCA?
ASCA (Accreditation Scheme for Conformity Assessment) is an FDA voluntary program established under Section 514(c) of the Federal Food, Drug, and Cosmetic Act, as amended by the 21st Century Cures Act. It operates through a two-tier structure:
Tier 1Accreditation Bodies
Organizations recognized by FDA to evaluate and accredit testing laboratories. The National Voluntary Laboratory Accreditation Program (NVLAP) is a primary FDA-recognized accreditation body under ASCA.
Tier 2Testing Laboratories
Laboratories recognized by FDA-accepted accreditation bodies for specific test methods, identified by TL (Test Level) numbers. A lab must hold current ISO/IEC 17025 accreditation AND receive FDA ASCA recognition for each TL number separately.
ⓘ Important distinction: NVLAP accreditation and FDA ASCA recognition are not the same thing. NVLAP accreditation is required for ASCA recognition, but ASCA recognition must be separately obtained and verified for each TL number. Compatible Electronics holds both NVLAP accreditation (Lab Code 200527-0) and FDA ASCA recognition for TL-80, TL-81, and TL-82.
Compatible Electronics ASCA Recognition
TL-80 — IEC 60601-1 Electrical Safety
General requirements for basic safety and essential performance of medical electrical equipment (Ed. 3.1)
- Dielectric strength (hipot) testing
- Leakage current — earth, enclosure, patient auxiliary
- Protective earth continuity testing
- Creepage and clearance measurements
- Abnormal operation and single fault condition testing
TL-81 — IEC 60601-1-2 Ed. 4 EMC Testing
Electromagnetic compatibility requirements and tests for medical electrical equipment and systems
- Radiated and conducted emissions (CISPR 11 Group 1 Class B)
- IEC 61000-3-2 harmonic current and IEC 61000-3-3 voltage flicker
- ESD immunity (IEC 61000-4-2) — professional healthcare facility and home healthcare levels
- Radiated RF immunity (IEC 61000-4-3) — 3 V/m to 10 V/m depending on environment
- EFT/Burst (IEC 61000-4-4), surge (IEC 61000-4-5), conducted RF (IEC 61000-4-6)
- Power frequency magnetic field (IEC 61000-4-8), voltage dips (IEC 61000-4-11)
TL-82 — IEC 61010-2-101 IVD Safety
Safety requirements for in vitro diagnostic (IVD) medical equipment
- Safety requirements specific to in vitro diagnostic equipment
- Applied under both the safety standard and in combination with IEC 61326-2-6 EMC for IVD equipment
How ASCA Benefits Your 510(k) Submission
- FDA reviewer receives test report with ASCA declaration and TL number
- FDA does not review laboratory competency — already verified through ASCA
- Test data accepted as technically valid without additional scrutiny
- Review proceeds directly to substantial equivalence analysis
- No AI requests related to laboratory qualifications or procedures
- Faster, more predictable total review timeline
- FDA reviewer must independently assess laboratory competency
- Reviewer evaluates accreditation, calibration records, test procedures
- May generate AI requests for additional laboratory documentation
- Review may be placed on hold pending laboratory clarification
- Test data may be questioned if reviewer questions lab credentials
- Slower, less predictable total review timeline
How to Use ASCA Testing in Your 510(k) Submission
1
Verify Current ASCA Recognition
Check the FDA ASCA database at fda.gov/medical-devices/asca-pilot-program for Compatible Electronics' current recognition status. Recognition must be current at the time of testing — verify before scheduling, not after.
2
Notify Us of the ASCA Intent When Scheduling
Inform Compatible Electronics that the tests will be used for a 510(k) ASCA submission when scheduling. We will ensure test reports are formatted and documented to meet ASCA requirements, including the ASCA declaration and TL number identification.
3
Request ASCA-Format Test Reports
Our ASCA reports include: ASCA declaration, NVLAP Lab Code 200527-0 accreditation statement, TL number identification, complete measurement data with calibration traceability, and all documentation required by FDA's ASCA guidance.
4
Reference ASCA in Your 510(k) Submission
Include the ASCA declaration in your 510(k) summary or substantial equivalence argument. Reference Compatible Electronics' NVLAP Lab Code 200527-0 and the relevant TL numbers. Follow FDA's current 510(k) guidance for ASCA submissions.
Important ASCA Considerations
ⓘ NoteASCA is Voluntary
You are not required to use an ASCA-recognized lab for a 510(k) submission. But using one significantly reduces the risk of test-related review delays — which are among the most common causes of 510(k) timeline overruns.
ⓘ NoteASCA is Test-Method Specific
Verify the TL number covers the exact standard edition you are testing to — TL-81 covers IEC 60601-1-2 Ed. 4. Confirm you are not submitting Ed. 3 data when Ed. 4 is preferred by current FDA reviewers.
ⓘ NoteASCA Covers the Lab, Not the Product
ASCA acceptance means FDA accepts the lab's test procedure as valid. The medical device itself must still demonstrate substantial equivalence through the standard 510(k) review process — ASCA does not provide device-level approval.
⚠ Verify before testing: ASCA recognition must be current at the time of testing — not just at the time of submission. Check the FDA ASCA database directly before scheduling your test session to confirm Compatible Electronics' recognition is active for the specific TL numbers you need.
Ready for ASCA-Recognized Medical Device Testing?
Contact Compatible Electronics for IEC 60601-1-2 Ed. 4 EMC testing, IEC 60601-1 safety testing, and IEC 61010-2-101 IVD safety under FDA ASCA recognition.
Brea: 714‑579‑0500 · Newbury Park: 805‑480‑4044
www.celectronics.com
