Accelerating FDA Approval: Leveraging the ASCA Program for Medical Device Compliance

The FDA’s Accreditation Scheme for Conformity Assessment (ASCA) lets medical device manufacturers submit test data from accredited laboratories in a standardized format the agency has already agreed to trust. In practice that means fewer deficiency letters, fewer questions about test methods, and a shorter, more predictable premarket review.   

FDA’s ASCA, launched as a pilot in 2020 and converted to a permanent program on 19 September 2023 under the Medical Device User Fee Amendments of 2022 (MDUFA V). The ASCA program covers biocompatibility testing and the basic safety and essential performance families under IEC 60601-1 and IEC 61010-1. This whitepaper by Element medical device expert Richard White explains how the scheme works, what it covers, and where its limits sit.

 

Does the FDA ASCA Program Apply to Your Device? 

If your device needs biocompatibility, electrical safety, or electromagnetic compatibility (EMC) testing to support a 510(k), De Novo, or PMA submission, ASCA is worth assessing before you book laboratory time. The whitepaper helps you:

• Confirm whether the standards and test methods your device relies on fall inside the current ASCA scope.
• Understand what an ASCA Summary Test Report contains and how it changes the way reviewers handle your data.
• Decide where ASCA data and non-ASCA data can sensibly be combined in a single submission.
• Identify the parts of your testing program, software validation and usability among them, that ASCA does not reach.
• Plan laboratory capacity early, given the limited pool of accredited laboratories.

 

Understanding the FDA ASCA Program: Abstract 

Conformity assessment is where a large share of avoidable submission delays originate. Reviewers routinely question test methodology, laboratory competence, and report completeness. Not because the device is unsafe, but because the evidence arrives in an unfamiliar shape. ASCA addresses that directly. Rather than assessing every test report on its own merits, the FDA recognizes accreditation bodies, which accredit laboratories against ISO/IEC 17025 plus FDA-specific program requirements, and those laboratories report in a format the agency has already defined.

 

This whitepaper sets out the scheme’s scope, the process from eligibility check to FDA response, and the pros and cons of the ASCA scheme.

 

Accelerating FDA Approval, Leveraging the ASCA Program for Medical Device Compliance: Excerpt

“The biggest misconception I encounter is that ASCA is a shortcut around FDA review. It is not. The testing is the same testing, to the same standards, and the agency still assesses the safety and effectiveness of the device. What changes is that the reviewer no longer has to work out whether they can trust the test report in front of them, because that question was settled at the accreditation stage. That is where the time is recovered.”

— Richard White, Medical Device Expert, Element

 

FDA Compliance Requirements for Medical Device Approval 

The FDA classifies devices into three risk classes, and the submission route follows from that classification. 

1. Class I devices are subject to general controls.
2. Class II devices require general and special controls, including performance standards and post-market surveillance, and most reach the market through a 510(k) demonstrating substantial equivalence to a predicate.
3. Class III devices carry life-supporting or life-sustaining functions and generally require premarket approval (PMA). De Novo classification covers novel low- to moderate-risk devices with no predicate.

 

Every route rests on evidence of conformity to FDA-recognized consensus standards. Declaring conformity is straightforward. Demonstrating it in a way that survives review is where timelines slip.

 

Routes to US Medical Device Compliance 

The traditional route involves third-party testing or in-house validation against recognized ISO, IEC, ANSI, and AAMI standards, followed by compilation of test reports and declarations of conformity into the submission package. Using these standards is voluntary, but conformity provides a presumption that the relevant requirements have been met.

The weakness is consistency. Because report formats, method descriptions, and levels of detail vary between laboratories, FDA reviewers frequently assess testing methodology and laboratory competence in depth before accepting results. Each round of questions adds weeks. ASCA was introduced to close that gap.

 

What Is the ASCA Program? 

ASCA is a voluntary scheme run by the FDA’s Center for Devices and Radiological Health, and its structure is layered. The FDA grants ASCA Recognition to accreditation bodies. Those bodies accredit testing laboratories against ISO/IEC 17025 and additional FDA program specifications. Accredited laboratories then test within their accredited scope and report in the standardized ASCA Summary Test Report format. 

The scheme currently covers two areas of testing:

• Biocompatibility testing – evaluating how device materials interact with biological systems, covering the most common methods in the ISO 10993 series.
• Basic safety, essential performance, and EMC – the IEC 60601-1 family for medical electrical equipment and the IEC 61010-1 family for laboratory medical equipment, including associated EMC standards.

That scope widens incrementally; full recognition of IEC 61326-2-6 in 2025, for example, extended the program to in-vitro diagnostic equipment manufacturers. The FDA publishes the current list of standards, recognized accreditation bodies, and accredited laboratories. You can find the list of ASCA-accredited labs here. 

 

How the ASCA Process Works 

1. Determine eligibility and scope. Establish whether the testing your device requires falls within an ASCA-recognized standard.
2. Engage an accredited laboratory. Define standards, methods, and endpoints, and verify the laboratory holds current accreditation for the specific standards involved. Accreditation is scope-specific, not general.
3. Conduct the conformity assessment. Supply samples and supporting documentation. The laboratory tests to FDA-recognized methods under ISO/IEC 17025 and ASCA supplemental requirements, documented traceably.
4. Receive the ASCA Summary Test Report. The report follows the FDA’s prescribed format, recording methods, equipment, conditions, and results alongside a declaration of conformity.
5. Prepare the submission. Incorporate the report into the 510(k), De Novo, or PMA package, state clearly that ASCA testing was used, and cross-reference the standards.
6. FDA review. Reviewers confirm the accredited status of the testing and assess on that basis. Where the report is complete and the standard applied correctly, further review of the underlying data is generally not required.

 

The FDA retains the right to ask questions if inconsistencies appear. What changes is the volume of those questions, not the agency’s authority to ask them.

Example flow chart comparing the ASCA approval process to the standard FDA approval process.

 

ASCA Compared With a Standard FDA Submission 

The differences are structural, affecting how conformity data is generated, documented, and reviewed:

 

 

Benefits and Limitations of the ASCA Program 

 

Benefits of the ASCA program 

The ASCA program offers manufacturers several benefits, including:

1. Predictable regulatory pathway
2. Reduced regulatory burden
3. Reduced time-to-market
4. Improved testing quality
5. Optimized resource allocation
6. Global regulatory alignment

 

Limitations and considerations for the ASCA program  

The ASCA program also has some limitations and considerations for manufacturers to make before using it:

1. Limited standard coverage
2. ASCA-accredited laboratory availability and capacity
3. FDA oversight still applies
4. ASCA summary test reports must follow FDA-prescribed formats
5. Ongoing monitoring and updates to standards, lab accreditations, and FDA guidance

 

How does the ASCA Program fit in a Global Compliance Strategy? 

ASCA is an FDA program, but few manufacturers build for the US alone. Under the EU Medical Device Regulation, conformity assessment is carried out by Notified Bodies where required, with emphasis on clinical evaluation, post-market surveillance, and unique device identification. ASCA emphasizes laboratory accreditation and standardized reporting. The two are not equivalent, but they share a foundation in the same IEC and ISO standards.

That overlap is the opportunity. Where an ASCA-recognized standard is also harmonized under EU MDR or accepted elsewhere, the same data can often support more than one submission. Planning across markets before testing begins, rather than retrofitting evidence afterwards, reduces duplication and cost. Acceptance still needs confirming jurisdiction by jurisdiction.

 

Conclusion: Is the FDA ASCA program right for you? 

The decision points are narrow, but if you get these four points right, the ASCA program does what it was designed to do:

1. Check your standards sit within the current scope.
2. Confirm the laboratory’s accreditation covers the specific methods you need.
3. Secure capacity early.
4. Treat the report format as a requirement rather than a preference.

 

Element supports medical device manufacturers with end-to-end Advisory, Testing, and Certification services, alongside global market access support. We operate the UK’s only ASCA-accredited test laboratory, accredited laboratories across the US, as well as a network of global NRTL-approved laboratories, so testing can be placed where it suits your program rather than where availability dictates. Contact us to learn more.

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