--- title: "ASCA Definition & Meaning | MedTech Terms" description: "FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/asca#term", "name": "Accreditation Scheme for Conformity Assessment", "alternateName": "ASCA", "description": "Under ASCA, FDA accepts test reports from accredited labs against eligible standards (e.g., portions of IEC 60601-1 and ISO 10993) with a presumption of conformity, reducing the likelihood of additional information requests during review.", "url": "https://medtechterms.com/terms/asca", "termCode": "asca", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/asca#article", "headline": "ASCA, Accreditation Scheme for Conformity Assessment", "description": "FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny.", "url": "https://medtechterms.com/terms/asca", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/asca" }, "about": { "@id": "https://medtechterms.com/terms/asca#term" }, "articleSection": "Regulatory", "inLanguage": "en", "keywords": "Accreditation Scheme for Conformity Assessment, ASCA, Regulatory, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "FDA - Medical Devices", "url": "https://www.fda.gov/medical-devices", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "European Commission - Medical Devices", "url": "https://health.ec.europa.eu/medical-devices-sector_en", "publisher": { "@type": "Organization", "name": "European Commission" } }, { "@type": "CreativeWork", "name": "IMDRF Documents", "url": "https://www.imdrf.org/documents", "publisher": { "@type": "Organization", "name": "IMDRF" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/recognized-standards#term", "name": "FDA Recognized Consensus Standards", "url": "https://medtechterms.com/terms/recognized-standards" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Regulatory", "item": "https://medtechterms.com/terms?cat=Regulatory" }, { "@type": "ListItem", "position": 4, "name": "Accreditation Scheme for Conformity Assessment", "item": "https://medtechterms.com/terms/asca" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/asca#faq", "mainEntity": [ { "@type": "Question", "name": "What is the primary benefit of using an ASCA-accredited lab?", "acceptedAnswer": { "@type": "Answer", "text": "The primary benefit is a presumption of conformity for test reports, which typically leads to a reduced likelihood of additional information requests from the FDA during the review process for eligible devices and standards." } }, { "@type": "Question", "name": "Are all medical device standards covered by ASCA?", "acceptedAnswer": { "@type": "Answer", "text": "No, ASCA applies only to a specific list of FDA-recognized consensus standards and test methods deemed eligible for the program. Manufacturers must consult FDA's ASCA program website for the current scope." } }, { "@type": "Question", "name": "Does ASCA apply to all types of medical device submissions?", "acceptedAnswer": { "@type": "Answer", "text": "While primarily impacting 510(k) submissions due to their frequent reliance on consensus standards, the principles of ASCA can contribute to efficiency in other submission types where eligible standards are applied, though the direct process benefits are most pronounced for 510(k)s." } }, { "@type": "Question", "name": "How does a lab become ASCA-accredited?", "acceptedAnswer": { "@type": "Answer", "text": "Testing laboratories willing to participate in ASCA must apply and demonstrate their competence to an ASCA-recognized accreditation body, which assesses their conformance to ISO/IEC 17025 and other ASCA program requirements." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Accreditation Scheme for Conformity Assessment [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)ASCA # Accreditation Scheme for Conformity Assessment FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Under ASCA, FDA accepts test reports from accredited labs against eligible standards (e.g., portions of [IEC 60601-1](/terms/iec-60601-1) and ISO 10993) with a presumption of conformity, reducing the likelihood of additional information requests during review. What the regulation says The FDA established the Accreditation Scheme for Conformity Assessment (ASCA) program to increase efficiency in the medical device review process. The program allows for the FDA to accept test reports from ASCA-accredited testing laboratories, particularly for certain eligible standards such as parts of [IEC 60601-1](/terms/iec-60601-1) and ISO 10993. This approach aims to provide a "reasonable assurance of conformity" with applicable FDA requirements, as outlined in FDA guidance documents on ASCA. ## What this means in practice Sponsors plan testing with ASCA-accredited labs to compress 510(k) review time on commonly tested standards. ## Examples - A MedTech manufacturer submitting a 510(k) for an electro-medical device uses an ASCA-accredited lab for biocompatibility testing according to ISO 10993-1, significantly streamlining the biocompatibility review process. - An in vitro diagnostic company leverages an ASCA-accredited facility for electromagnetic compatibility (EMC) testing against IEC 60601-1-2, reducing the timeline for FDA's assessment of EMC data. - A company developing a new surgical tool sends its product for electrical safety testing per IEC 60601-1 to an ASCA-accredited lab, anticipating a more efficient FDA review of those specific test results. Common pitfalls - • Misinterpreting ASCA as a blanket approval for all testing, rather than a program for specific eligible standards and tests. - • Failing to verify that the chosen laboratory is actively accredited under ASCA for the specific standard and test method required. - • Submitting ASCA-generated test reports without proper documentation or in a format not aligned with FDA guidance for ASCA submissions. - • Believing that ASCA eliminates all potential for FDA additional information requests related to testing, which is not guaranteed. - • Not understanding that ongoing surveillance and re-accreditation are part of the ASCA program for laboratories, impacting the validity of older reports. ## Frequently asked questions What is the primary benefit of using an ASCA-accredited lab? The primary benefit is a presumption of conformity for test reports, which typically leads to a reduced likelihood of additional information requests from the FDA during the review process for eligible devices and standards. Are all medical device standards covered by ASCA? Does ASCA apply to all types of medical device submissions? How does a lab become ASCA-accredited? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory FDA Recognized Consensus Standards Voluntary standards that FDA has formally recognized for use in establishing device conformity. ](/terms/recognized-standards) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory 510(k) Summary vs 510(k) Statement Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 European Commission· 1 IMDRF· 1 1. [1 FDA - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices) 2. [2 European Commission - Medical Devices Verified European Commission · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) 3. [3 IMDRF Documents Verified IMDRF · imdrf.org ](https://www.imdrf.org/documents) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Acronym ASCA Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=asca) Learn in 60 seconds Card Lesson Quiz FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny. - · Sponsors plan testing with ASCA-accredited labs to compress 510(k) review time on commonly tested standards. Remember this Watch out: Misinterpreting ASCA as a blanket approval for all testing, rather than a program for specific eligible standards and tests. Related terms - [FDA Recognized Consensus Standards ](/terms/recognized-standards) You may also need Auto-suggested from Regulatory and shared keywords. - [Genetic Testing Requirements (IVDR Article 4) ](/terms/ivdr-genetic-testing) - [Notified Body Scrutiny (IVDR Class D) ](/terms/ivdr-notified-body-scrutiny) - [Breakthrough Device Designation(BDD) ](/terms/breakthrough-device) - [AI Act Conformity Assessment (Medical Devices) ](/terms/ai-act-conformity-assessment) - [CE Mark ](/terms/ce-mark) - [Common Specifications(CS) ](/terms/common-specifications) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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