FDA Accreditation Scheme for Conformity Assessment (ASCA)
Compatible Electronics, Inc. is an FDA ASCA-Accredited testing laboratory at all three Southern California locations, listed under ASCA ID# TL-80, TL-81, and TL-82. Our ASCA-accredited test reports for IEC 60601-1, IEC 60601-1-2, IEC 61010-1, and other eligible standards can accompany FDA premarket submissions, giving the FDA enhanced confidence in testing results without additional methodology review.
What Is the FDA ASCA Program?
The FDA Accreditation Scheme for Conformity Assessment (ASCA) is a program under which the FDA grants ASCA Recognition to qualified accreditation bodies, which in turn accredit testing laboratories that conduct premarket testing for medical device manufacturers. A testing laboratory that achieves ASCA Accreditation has demonstrated competency in performing tests to specific FDA-recognized consensus standards, and its reports carry enhanced weight in FDA premarket submissions.
Under the ASCA Program, when a device manufacturer submits a Declaration of Conformity with an ASCA Summary Test Report as part of their premarket submission (510(k), De Novo, or PMA), the FDA will not request additional information regarding the laboratory's testing methodologies — a significant time-saving benefit in the review process.
Compatible Electronics is one of a limited number of laboratories authorized by the FDA under this program. Our laboratory holds ISO/IEC 17025:2017 accreditation from NVLAP (Lab Code 200527-0) and is listed on the FDA ASCA-Accredited Testing Laboratories page for all three of our facilities.
Our FDA ASCA Listings
Compatible Electronics holds ASCA Accreditation at each of our three Southern California facilities, each carrying its own ASCA ID. Manufacturers can verify our standing directly on the FDA's official listing page.
Lake Forest / Silverado — ASCA TL-80
- 20621 Pascal Way, Lake Forest/Silverado, CA 92630
- Primary facility — full scope of ASCA-eligible standards
- IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-8, 60601-1-11
- IEC 61010-1 (FDA#19-34)
- View TL-80 FDA Listing ↗
Brea — ASCA TL-81
- 114 Olinda Drive, Brea, CA 92823
- IEC 60601-1-2 Ed. 4.1 (FDA#19-36) — EMC testing
- IEC 60601-1-8 Ed. 2.1 / 2.2 (FDA#5-76, #5-131)
- Supports concurrent EMC and safety campaigns
- View TL-81 FDA Listing ↗
Newbury Park — ASCA TL-82
- 1050 Lawrence Drive, Newbury Park, CA 91320
- IEC 60601-1-2 Ed. 4.1 (FDA#19-36) — EMC testing
- IEC 60601-1-11 Ed. 2.1 (FDA#19-38) — Home healthcare
- Supports overflow and parallel scheduling
- View TL-82 FDA Listing ↗
ASCA-Eligible Standards We Test To
Our NVLAP scope includes all major ASCA-eligible standards drawn from the IEC 60601 and IEC 61010 families. The FDA# designations below correspond to the FDA's recognition numbers for each standard version. These are the standards for which Compatible Electronics can generate an ASCA Summary Test Report.
General Safety — IEC 60601-1
- ANSI/AAMI ES60601-1:2005/A2:2021 (FDA#19-46) — US national standard including AMD2:2021
- IEC 60601-1:2005/A2:2020 — International 3rd edition with Amendment 2
- IEC 60601-1, 3rd Ed. (2005) + A1 (2012)
- EN 60601-1:2006 + A1:2013 / + A12:2014 — European versions
EMC — IEC 60601-1-2
- IEC 60601-1-2, Ed. 4.1 (2020-09) (FDA#19-36) — current ASCA-recognized version
- IEC 60601-1-2, Ed. 4.0 (2014) + A1 (2020)
- IEC 60601-1-2, Ed. 4 (2014-02)
- EN 60601-1-2:2015 — European version (Ed. 4)
Usability — IEC 60601-1-6
- IEC 60601-1-6, Ed. 3.2 (2020-07) (FDA#5-132) — current ASCA-recognized version
- IEC 60601-1-6, Ed. 3.1 (2013-10) (FDA#5-89)
- IEC 60601-1-6, Ed. 3.0 (2010) + A1 (2013)
- EN 60601-1-6:2010 / :2007 — European versions
Alarm Systems — IEC 60601-1-8
- IEC 60601-1-8, Ed. 2.2 (2020-07) (FDA#5-131) — current ASCA-recognized version
- IEC 60601-1-8, Ed. 2.1 (2012-11) (FDA#5-76)
- IEC 60601-1-8, Ed. 2.0 (2006)
- EN 60601-1-8:2004 + A1:2006
Home Healthcare — IEC 60601-1-11
- IEC 60601-1-11, Ed. 2.1 (2020-07) (FDA#19-38) — current ASCA-recognized version
- IEC 60601-1-11, Ed. 2.0 (2015-01) (FDA#19-14)
- EN 60601-1-11:2015
Lab & Measurement Equipment — IEC 61010-1
- IEC 61010-1, Ed. 3.1 (2017-01) (FDA#19-34) — ASCA-recognized version
- IEC 61010-1 Ed. 3.0 + A1 (2016-12)
- EN 61010-1:2010 + A1:2019
- EN 61010-1 (2010)
ⓘ The FDA does not require all normative references in FDA-recognized standards to themselves be FDA-recognized. Where test plans incorporate updated collateral standard editions (e.g., IEC 60601-1 ed. 3.2 clauses referenced in the 2020 collaterals), the ASCA Summary Test Report should highlight specific deviations and explain the rationale. Compatible Electronics engineers are experienced in documenting these nuances correctly for FDA review.
How the ASCA Program Works
The ASCA program establishes a structured relationship between the FDA, accreditation bodies, testing laboratories, and device manufacturers. Understanding each party's role helps manufacturers plan their testing and submission strategy effectively.
1
FDA Grants ASCA Recognition
The FDA grants ASCA Recognition to qualified accreditation bodies (such as NVLAP) that demonstrate competency in accreditation activities under the ASCA program specifications.
2
Accreditation Body Accredits Lab
NVLAP assesses Compatible Electronics against ISO/IEC 17025:2017 plus the FDA ASCA program specifications for each eligible standard. Upon satisfactory assessment, ASCA Accreditation is granted.
3
Manufacturer Elects ASCA Testing
A device manufacturer may elect to use Compatible Electronics as an ASCA-accredited laboratory for FDA premarket submissions. The manufacturer remains ultimately responsible for appropriate standard selection and test plan development.
4
Collaborative Test Plan Development
Unlike pre-ASCA practice where manufacturers typically dictated the test plan, ASCA allows Compatible Electronics to take a more active role — reviewing the plan, providing feedback based on standards expertise, and requesting FDA guidance where essential performance or other complex questions arise.
5
Testing & ASCA Summary Test Report
Compatible Electronics performs all required tests and compiles an ASCA Summary Test Report. This report is purpose-built for FDA premarket submissions and documents that testing was conducted by an ASCA-accredited laboratory using ASCA-compliant methods.
6
FDA Submission with Declaration of Conformity
The manufacturer submits the ASCA Summary Test Report alongside a Declaration of Conformity as part of the 510(k), De Novo, or other premarket submission. The FDA will not request additional information about testing methodologies — reducing review time and back-and-forth.
Test Plan Development & Essential Performance
The manufacturers are ultimately responsible for the test plan and the appropriate selection and use of recognized consensus standards, including ISO 13485 Quality Management Systems and ISO 14971 Risk Management. However, through ASCA, Compatible Electronics is able to take a more active role in developing the plan. The test plan will be guided by IEC 60601-1, IEC 60601-1-2, and any relevant FDA published guidance documents.
Essential performance is a nuanced topic and a common source of confusion. Occasionally the FDA sees test reports (outside of ASCA) with essential performances that don't make sense — such as listing a "remote controller" as essential performance for a device where it is not. If Compatible Electronics has questions about the essential performances identified in the test plan, the ASCA framework allows us to request additional FDA guidance via the ASCA summary test plan report. This prevents downstream questions from the FDA and helps streamline the path to clearance.
If the test lab has questions with aspects of the test plan, the test lab can send a request in the ASCA summary test plan report to receive additional guidance from the FDA, which helps streamline the testing requirements that will be part of the 510(k) submittal or letter-to-file FDA path.
🔎 The 2018 FDA guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices provides helpful information regarding declarations of conformity and their essential role in regulatory review. Manufacturers should continue to rely on other FDA-recognized standards and provide conformance declarations in premarket submissions; however, only ASCA-eligible standards qualify for the streamlined review benefits of the ASCA Program.
ASCA Program Scope: Cross-Cutting & Device-Specific Standards
In accordance with the MDUFA IV commitment letter, the ASCA includes both cross-cutting (horizontal) and device-specific (vertical) standards that are of public health significance and provide the means to establish acceptance criteria. The FDA selected standards and tests from the biocompatibility, basic safety, and essential performance series based on input from the medical device community.
Cross-Cutting (Horizontal) Standards
- Basic safety and essential performance — IEC 60601-1 family (general + collateral standards)
- EMC for medical electrical equipment — IEC 60601-1-2
- Usability engineering — IEC 60601-1-6
- Alarm systems — IEC 60601-1-8
- Home healthcare environment — IEC 60601-1-11
- Measurement & laboratory equipment safety — IEC 61010-1
Device-Specific (Vertical) Standards
- IEC 60601-2-2 — High frequency surgical equipment
- IEC 60601-2-4 — Cardiac defibrillators
- IEC 60601-2-12 — Critical care ventilators
- IEC 60601-2-24 — Infusion pumps and controllers
- IEC 60601-2-35 — Medical heating blankets, pads, mattresses
Biocompatibility
- ISO 10993 series — Biological evaluation of medical devices (where within ASCA scope)
- See FDA guidance: Biocompatibility Testing of Medical Devices — Standards Specific Information for the Accreditation Scheme
Quality & Risk Management (Referenced)
- ISO 13485 — Quality management systems for medical devices
- ISO 14971 — Application of risk management to medical devices
- These are referenced in test plan development; manufacturers are responsible for their implementation
ASCA Key Terms & Definitions
The following definitions are drawn directly from FDA ASCA program guidance and are used consistently throughout the program.
Standards Recognition
The process by which the FDA identifies standards to which manufacturers of medical devices may submit a declaration of conformity to demonstrate compliance with pertinent FD&C Act provisions.
ASCA Recognition
A status granted by the FDA to accreditation bodies that demonstrate competency in accreditation activities by completing the application process outlined in the ASCA program guidance. ASCA-recognized accreditation bodies may accredit qualified testing laboratories.
Accreditation
Third-party attestation that a conformity assessment body (such as a testing laboratory) has formally demonstrated its competence to perform specific conformity assessment tasks. (ISO/IEC 17000:2004)
ASCA Accreditation
A status given by the FDA to testing laboratories that indicate testing competency through the application process outlined in the ASCA program guidance. Distinct from any ISO/IEC 17025 accreditation that an accreditation body grants for other purposes.
ASCA Summary Test Report
A report included in a manufacturer's premarket submission to the FDA, together with a Declaration of Conformity. This summary report decreases the need for the FDA to request additional information regarding testing methodologies.
Declaration of Conformity (DoC)
A manufacturer's statement that their device conforms to a specific FDA-recognized standard. When submitted with an ASCA Summary Test Report, the DoC carries enhanced weight in the premarket review process.
Suspension of ASCA Accreditation
Imposing temporary restrictions on one or more FDA-recognized consensus standards or test methods within a testing laboratory's scope of ASCA Accreditation.
Withdrawal of ASCA Accreditation
Cancelling the full scope of a testing laboratory's ASCA Accreditation; removes the organization entirely from the ASCA Program.
FDA ASCA Guidance Documents
The following FDA guidance documents are relevant to the ASCA program and to premarket submissions involving declarations of conformity. Manufacturers should consult these alongside the specific standard requirements.
Primary ASCA Program Guidance
Safety & Performance Guidance
Biocompatibility Guidance
🔎 For a plain-language explanation of how the ASCA program affects your FDA submission strategy, see our resource page: FDA ASCA Explained.
Why Compatible Electronics for ASCA Testing?
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Three ASCA-Accredited Facilities — ASCA ID TL-80 (Lake Forest), TL-81 (Brea), TL-82 (Newbury Park); parallel and overflow scheduling available
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NVLAP Accredited, ISO/IEC 17025:2017 — Lab Code 200527-0; the underlying ISO/IEC 17025 accreditation is a prerequisite for ASCA Accreditation
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ILAC-MRA Recognized — test data accepted in 100+ countries; a single test campaign can support FDA ASCA submission, NRTL listing, and international IEC 60601-1 compliance simultaneously
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Active Test Plan Collaboration — ASCA allows our engineers to actively guide test plan development, flag essential performance questions, and request FDA guidance — reducing downstream surprises
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Efficient Scheduling — safety, EMC, usability, and alarm systems testing conducted concurrently to minimize total project time
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Founded 1985 — 40 years of medical device testing experience; engineers familiar with IEC 60601 standard interpretation and FDA submission requirements
Related Medical Device Testing & Certification Services
ASCA accreditation supports premarket submission testing across a broad suite of IEC 60601-1 standards. The services below are most commonly requested alongside ASCA testing.
Ready to Submit Under ASCA?
Contact Compatible Electronics to discuss your FDA premarket submission testing. We'll identify the applicable ASCA-eligible standards, outline the test plan, and provide a quote for all three facilities.
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