--- title: "FDA Recognized Consensus Standards… | MedTech Terms" description: "Voluntary standards that FDA has formally recognized for use in establishing device conformity. 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[Regulatory](/terms?cat=Regulatory) 6. / 7. FDA Recognized Consensus Standards [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets) # FDA Recognized Consensus Standards Voluntary standards that FDA has formally recognized for use in establishing device conformity. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition FDA's Recognized Consensus Standards database lists ISO, IEC, ASTM, [AAMI](/terms/aami), and other standards that sponsors can declare conformity to via a Standards Data Report, simplifying review of the corresponding submission elements. What the regulation says The FDA actively encourages the use of recognized consensus standards to streamline the premarket review process for medical devices. By declaring conformity to an FDA-recognized standard, manufacturers can often reduce the amount of data required in a premarket submission, as outlined in FDA guidance documents like "Recognition and Use of Consensus Standards" (2018). This approach helps both manufacturers by clarifying expectations and the FDA by focusing review resources. ## What this means in practice Choosing recognized standards (and citing the recognition number) is the cleanest way to streamline 510(k) and [De Novo](/terms/de-novo) reviews. ## Examples - A manufacturer of a new infusion pump ensures its electromagnetic compatibility (EMC) testing follows IEC 60601-1-2, an FDA-recognized standard for medical electrical equipment, and cites the recognition number in their 510(k) submission. - A software developer for a medical device incorporates cybersecurity controls compliant with IEC 80001-1, an FDA-recognized standard for risk management of IT networks in healthcare, to address cybersecurity concerns. - A company developing a biological diagnostic test conducts performance validation according to an ASTM standard, which is recognized by the FDA for specific analytical methods, reducing the need for extensive raw data submission. Common pitfalls - • Manufacturers sometimes assume that demonstrating conformity to a recognized standard automatically guarantees market clearance, which is not always the case, as the FDA still performs a comprehensive review. - • A common pitfall is failing to cite the specific recognition number of the standard in regulatory submissions, which can lead to delays as reviewers must independently verify the standard's status. - • Over-reliance on recognized standards without thoroughly understanding their applicability to a specific device can result in inadequate testing or documentation. - • Confusing "recognized consensus standards" with general industry best practices can lead to submissions that do not meet FDA expectations. - • Ignoring updates to recognized standards or the FDA's recognition status can lead to submitting outdated information, requiring resubmission or additional data. ## Frequently asked questions How do recognized standards streamline the 510(k) review process? By demonstrating conformity to an FDA-recognized standard, manufacturers can often summarize test data or provide declarations of conformity in their 510(k) submissions, reducing the need for detailed test reports. This simplifies the review process for both the manufacturer and the FDA. Are all consensus standards recognized by the FDA? What is the benefit of citing the recognition number? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory Accreditation Scheme for Conformity Assessment(ASCA) FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny. ](/terms/asca) ### 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· 2 RAPS· 1 1. [1 FDA Standards Database Verified FDA · accessdata.fda.gov ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm) 2. [2 RAPS Regulatory Focus Verified RAPS · raps.org ](https://www.raps.org/news-and-articles/news-articles) 3. [3 FDA - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices) 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 Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=recognized-standards) Learn in 60 seconds Card Lesson Quiz Voluntary standards that FDA has formally recognized for use in establishing device conformity. - · Choosing recognized standards (and citing the recognition number) is the cleanest way to streamline 510(k) and De Novo reviews. Remember this Watch out: Manufacturers sometimes assume that demonstrating conformity to a recognized standard automatically guarantees market clearance, which is not always the case, as the FDA still performs a comprehensive review. Related terms - [Accreditation Scheme for Conformity Assessment(ASCA) ](/terms/asca) You may also need Auto-suggested from Regulatory and shared keywords. - [Abbreviated 510(k) ](/terms/abbreviated-510k) - [Modular PMA ](/terms/pma-modular) - [Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub) ](/terms/q-sub) - [Risk-Based Monitoring(RBM) ](/terms/risk-based-monitoring) - [Refuse to Accept(RTA) ](/terms/rta) - [510(k) Summary vs 510(k) Statement ](/terms/510k-summary-vs-statement) [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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