Examples
Worked examples
- Is an instance
A manufacturer submitting an Abbreviated 510(k) for an infusion pump cites IEC 60601-1 (general safety and essential performance for medical electrical equipment) and ANSI/AAMI/IEC 62366-1 (usability engineering) as FDA Recognized Consensus Standards, filing a Declaration of Conformity for each rather than submitting the complete underlying bench-test data package for independent FDA review of every requirement in those standards.
- Is an instance
A sponsor conducting a foreign clinical investigation under ISO 14155:2020 (Clinical investigation of medical devices for human subjects -- Good clinical practice) can rely on FDA's recognition of that standard, listed in the Recognized Consensus Standards database, to support acceptance of that trial's data in an IDE, 510(k), De Novo, or PMA submission.
Counter-examples
Looks similar, but isn't
- Not an instance
A manufacturer builds its device to the most current published edition of an ASTM mechanical-testing standard, but FDA's database currently lists only an older edition (or the standard at all) as recognized. Citing the newer edition via a Declaration of Conformity does not get the streamlined review treatment until FDA updates its recognition entry -- the submission has to either address the older recognized version, request recognition of the new edition, or submit full supporting data as it would for any non-recognized standard.
- Not an instance
A submission simply states the device 'meets applicable ISO and IEC standards' without identifying the specific recognized standard, recognition number, and extent of recognition, and without the required Declaration of Conformity elements (a statement of conformity, or of conformity with specified deviations, plus a brief description of test methods/summary of results). This is not a valid use of the recognized-standards pathway -- FDA guidance (Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices, September 2018) sets out what a compliant Declaration of Conformity must contain.
Editorial commentary
FDA maintains a public, searchable database — Recognized Consensus Standards: Medical Devices — listing the voluntary consensus standards it has formally recognized as suitable to support premarket submissions. The database, not a standard’s general industry acceptance, is the controlling record: FDA updates it as recognition decisions are made, often before the formal announcement is published in the Federal Register.
Why the program exists
Before this mechanism, a manufacturer citing an ISO, ASTM, AAMI, or IEC standard still generally had to submit the underlying test data for FDA reviewers to independently evaluate against that standard’s requirements. The FDA Modernization Act of 1997 amended Section 514 of the Federal Food, Drug, and Cosmetic Act to let FDA formally recognize consensus standards developed by external standards development organizations (SDOs), so that a manufacturer could instead file a Declaration of Conformity — a statement that the device conforms to a recognized standard, or conforms with disclosed deviations, plus a summary of test methods and results — in place of the full test report. This reduces review burden on both the submitter and FDA for well-established, agency-vetted testing methodologies, while FDA retains the ability to request the underlying data if reviewers need it.
How recognition and use work in practice
- Recognition is standard-specific and editioned. FDA recognizes a particular edition/version of a standard, not the standard’s title in the abstract; a superseding edition needs its own recognition decision before a Declaration of Conformity to that newer edition qualifies for the streamlined pathway.
- Extent of recognition varies. FDA may recognize a standard in full, in part, or with specific FDA-identified deviations noted in the database entry — the Declaration of Conformity has to reflect that exact scope.
- The Declaration of Conformity itself is not a data dump. Per FDA’s September 2018 guidance, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices, a compliant declaration identifies the standard and recognition number, states conformity (or conformity with specified deviations), and briefly describes the test methods used and a summary of results — not the full underlying dataset.
- It supports multiple submission types, not only 510(k): recognized-standard data and declarations can support Investigational Device Exemption (IDE), 510(k), De Novo, and Premarket Approval (PMA) submissions. Within the 510(k) pathway specifically, reliance on recognized consensus standards is a defining feature of the Abbreviated 510(k) route.
- Recognition can be withdrawn or limited. A standard can lose recognition, or have its extent of recognition narrowed, if FDA determines it no longer adequately supports a marketing decision — so a Declaration of Conformity filed against a standard’s current database entry is the safe practice, not reliance on a standard’s status at some earlier point.
How this differs from citing the standard generally
Plenty of ISO, ASTM, and AAMI standards are widely used in device development without ever appearing in FDA’s Recognized Consensus Standards database, and manufacturers can still build to them — they simply do not unlock the Declaration of Conformity shortcut. Conversely, a standard’s presence in the database does not mean FDA has independently re-validated every clause; recognition is a determination that conformity to the standard, demonstrated appropriately, is adequate evidence for the specific regulatory purpose FDA has assigned it.
Related CASRAI content
See ISO 14155 for a worked example of one specific FDA-recognized clinical-investigation standard, and the FDA 510(k) Premarket Notification guide and FDA medical device regulation and classification guide for how the Abbreviated 510(k) pathway uses recognized standards within the broader submission process.
Machine-readable encodings
Use in your systems
<role vocab="credit"
vocab-identifier="https://casrai.org/dictionary/"
vocab-term="FDA Recognized Consensus Standards"
vocab-term-identifier="https://casrai.org/dictionary/term/fda-recognized-consensus-standards" />{
"@context": "https://schema.org",
"@type": "DefinedTerm",
"@id": "https://casrai.org/dictionary/term/fda-recognized-consensus-standards",
"name": "FDA Recognized Consensus Standards",
"identifier": "https://casrai.org/dictionary/term/fda-recognized-consensus-standards",
"description": "An FDA Recognized Consensus Standard is a voluntary standard developed by a recognized standards development organization (SDO) -- such as ISO, ASTM International, AAMI, IEC, or CLSI -- that FDA has formally reviewed and added to its 'Recognized Consensus Standards: Medical Devices' database. A standard qualifies as an instance of this category only once FDA has completed its own review and listed it (with a recognition number and a stated extent of recognition -- full, partial, or recognized with FDA-identified deviations); merely being a published ISO/ASTM/AAMI standard, or being commonly cited in industry practice, is not sufficient on its own. Recognition lets a device manufacturer submit a Declaration of Conformity (DoC) to that standard in a premarket submission -- attesting the device conforms (in full or with disclosed deviations) and providing a summary of test methods and results -- rather than submitting the full underlying test data for independent FDA review. The legal basis is Section 514 of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Modernization Act of 1997 (FDAMA), which directed FDA to establish this recognition process specifically to reduce duplicative review burden for both industry and the agency. FDA can also withdraw or limit recognition (for example when a standard is superseded by a newer edition), so the database -- not the standard's existence or prior use -- is the authoritative, current record of what may be cited via a DoC at any given time.",
"inDefinedTermSet": "https://casrai.org/dictionary/domain/clinical-research#set",
"url": "https://casrai.org/dictionary/term/fda-recognized-consensus-standards",
"sameAs": [],
"license": "https://creativecommons.org/licenses/by/4.0/",
"publisher": {
"@id": "https://casrai.org/#organization"
},
"dateModified": "2026-07-18T06:30:51",
"inLanguage": "en"
}
