--- title: "ACNU Definition & Meaning | MedTech Terms" description: "FDA's 2024 final rule creating a pathway for nonprescription drug products that rely on additional conditions (e.g., self-selection tools, drug-device…" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/acnu#term", "name": "Additional Condition for Nonprescription Use", "alternateName": "ACNU", "description": "An Additional Condition for Nonprescription Use (ACNU) is a labeling or implementation condition, beyond conventional Drug Facts labeling, that FDA may require for a nonprescription drug product to assure consumers can self-select and self-use the product safely. ACNUs may include digital self-assessment apps, device-mediated questionnaires, response-based vending, or other technological gating mechanisms. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Additional Condition for Nonprescription Use [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)[Startup Lifecycle](/ecosystems/startup-lifecycle)ACNU # Additional Condition for Nonprescription Use FDA's 2024 final rule creating a pathway for nonprescription drug products that rely on additional conditions (e.g., self-selection tools, drug-device combinations) to ensure safe use without a healthcare provider. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed June 20, 2026 ## Definition An Additional Condition for Nonprescription Use (ACNU) is a [labeling](/terms/labeling) or implementation condition, beyond conventional Drug Facts labeling, that FDA may require for a nonprescription drug product to assure consumers can self-select and self-use the product safely. ACNUs may include digital self-assessment apps, device-mediated questionnaires, response-based vending, or other technological gating mechanisms. The final rule (Dec 2024) creates an explicit regulatory framework for products that would otherwise be unable to switch from Rx to OTC because labeling alone cannot ensure [safe](/terms/safe-note) use. What the regulation says 21 CFR Part 330 amended by the December 2024 ACNU final rule. Combination products with an ACNU device component are subject to [combination product](/terms/combination-product) jurisdiction under 21 CFR Part 3. ## What this means in practice ACNU is highly relevant to drug-device combination products and [digital therapeutics](/terms/digital-therapeutics) that act as the 'additional condition' enabling [safe](/terms/safe-note) OTC use. Examples include app-mediated screening for hormonal contraceptives, device-confirmed glucose checks for OTC insulin pens, or AI-assisted symptom triage gating access to a Rx-to-OTC switch. Manufacturers building these conditions must meet medical device requirements (often as a [SaMD](/terms/samd)) in parallel with the drug NDA/ANDA pathway. Common pitfalls - • Treating an ACNU app as marketing software, it is part of the labeling and likely a regulated medical device. - • Failing to integrate human factors testing of the ACNU early, FDA expects evidence the additional condition actually achieves safe self-selection. - • Ignoring post-market obligations, manufacturers must monitor whether the ACNU continues to function as intended in real-world use. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory Combination Product Product comprised of two or more regulated components - e.g., drug-device, biologic-device. ](/terms/combination-product)[ Regulatory Labeling All written, printed, or graphic matter on or accompanying a device. ](/terms/labeling)[ Market Segments Digital Therapeutics(DTx) Software-based interventions that prevent, manage, or treat disease. ](/terms/digital-therapeutics)[ Clinical & Trials Human Factors Engineering(HFE) Engineering discipline focused on safe and effective device use by intended users. ](/terms/human-factors) ### 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 (3) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) - [Startup Lifecycle](/ecosystems/startup-lifecycle) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 Federal Register· 1 FDA· 1 European Commission· 1 1. [1 FDA ACNU Final Rule (Dec 2024) Verified Federal Register · federalregister.gov ](https://www.federalregister.gov/documents/2024/12/26/2024-30387/nonprescription-drug-product-with-an-additional-condition-for-nonprescription-use) 2. [2 FDA ACNU Web Page Verified FDA · fda.gov ](https://www.fda.gov/drugs/drug-information-consumers/nonprescription-drug-products-additional-condition-nonprescription-use) 3. [3 European Commission - Medical Devices Verified European Commission · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) 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 ACNU Sources 3 Updated 6/20/2026 [Compare with another term](/compare?a=acnu) Learn in 60 seconds Card Lesson Quiz FDA's 2024 final rule creating a pathway for nonprescription drug products that rely on additional conditions (e.g., self-selection tools, drug-device combinations) to ensure safe use without a healthcare provider. - · ACNU is highly relevant to drug-device combination products and digital therapeutics that act as the 'additional condition' enabling safe OTC use. - · Examples include app-mediated screening for hormonal contraceptives, device-confirmed glucose checks for OTC insulin pens, or AI-assisted symptom triage gating access to a Rx-to-OTC switch. - · Manufacturers building these conditions must meet medical device requirements (often as a SaMD) in parallel with the drug NDA/ANDA pathway. Remember this Watch out: Treating an ACNU app as marketing software, it is part of the labeling and likely a regulated medical device. Related terms - [Combination Product ](/terms/combination-product) - [Software as a Medical Device(SaMD) ](/terms/samd) - [Human Factors Engineering(HFE) ](/terms/human-factors) - [Digital Therapeutics(DTx) ](/terms/digital-therapeutics) - [Labeling ](/terms/labeling) You may also need Auto-suggested from Regulatory and shared keywords. - [Emergency Use Authorization(EUA) ](/terms/eua) - [Importer and Distributor Obligations (EU) ](/terms/importer-distributor) - [Algorithm Change Protocol(ACP) ](/terms/algorithm-change-protocol) - [ICH E6(R3) Good Clinical Practice(E6(R3)) ](/terms/ich-e6-r3) - [Legacy Device Cybersecurity ](/terms/legacy-device-cyber) - [NIST IR 8473, Cybersecurity Framework Profile for HPH(NIST IR 8473) ](/terms/nist-cswp-35) [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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