ASCA-Recognized Medical Device Testing for FDA Submissions
Compatible Electronics is recognized under the FDA's Accreditation Scheme for Conformity Assessment (ASCA) program. Our test reports are accepted by the FDA without additional technical review, providing a faster, more predictable pathway to 510(k) clearance for your medical devices.
What is FDA ASCA?
The Accreditation Scheme for Conformity Assessment (ASCA) is an FDA program that recognizes testing laboratories whose reports can be accepted without routine FDA review. ASCA-recognized labs must meet rigorous competency requirements and maintain ISO/IEC 17025 accreditation for specific test methods.
Our FDA ASCA Recognition
TL-80: IEC 60601-1 Electrical Safety Testing
Comprehensive electrical safety testing for medical electrical equipment including leakage current, dielectric strength, and protection verification.
TL-81: IEC 60601-1-2 EMC Testing
Complete electromagnetic compatibility testing including emissions, immunity, and essential performance verification.
TL-82: IEC 61010-2-101 IVD Equipment Safety
Safety testing for in vitro diagnostic medical equipment used in clinical laboratories.
Supporting Credentials
- NVLAP Accreditation (Lab Code 200527-0)
- ISO/IEC 17025:2017 Compliance
- Regular FDA and accreditation body audits
Benefits of ASCA Testing
Faster Review
- FDA accepts test reports without additional review
- Faster 510(k) review times
- More predictable submission timeline
Reduced Risk
- Reduced FDA questions on test data
- Lower risk of testing-related delays
- Confidence in regulatory acceptance
Streamlined Process
- No lab competency evaluation needed
- Test method validation pre-approved
- Direct path to market clearance
Quality Assurance
- Rigorous competency requirements
- ISO/IEC 17025 accredited
- Regular FDA oversight
ASCA vs. Non-ASCA Testing
The ASCA Advantage
When you submit a 510(k) with test reports from a non-ASCA laboratory, FDA reviewers must evaluate the laboratory's competency and the validity of test methods. With ASCA reports, this review is not required - the FDA trusts our demonstrated competency, speeding your path to market.
ASCA recognition means your test reports are pre-approved for FDA acceptance
Standards Covered Under Our Recognition
IEC 60601-1 General Safety
- IEC 60601-1 Ed. 3.1 (2012)
- IEC 60601-1 Ed. 3.2 (2020)
- ANSI/AAMI ES60601-1 - US National Differences
IEC 60601-1-2 EMC
- IEC 60601-1-2 Ed. 4.0 (2014)
- IEC 60601-1-2 Ed. 4.1 (2020)
- Essential performance verification
IEC 61010-2-101 IVD Safety
- IEC 61010-2-101 Ed. 2.0
- IEC 61010-2-101 Ed. 2.1
- In vitro diagnostic equipment
Collateral & Particular Standards
- Applicable collateral standards (60601-1-X series)
- Particular standards (60601-2-XX series)
- Comprehensive device coverage
How to Work With Us
1. Early Consultation
Contact us early in your development process for test planning and regulatory strategy.
2. Device Review
We review your device classification and intended use to determine applicable standards.
3. Test Planning
Develop comprehensive test plan aligned with FDA expectations and ASCA requirements.
4. Testing & Documentation
Execute testing with full documentation and deliver ASCA-recognized test reports.
5. Submission Support
Support your 510(k) submission with technical expertise as needed.
Accelerate Your FDA Clearance with ASCA Testing
Contact our FDA ASCA recognized laboratory for faster, more predictable 510(k) submissions.
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