--- title: "BDD, Breakthrough Device Designation | MedTech Terms" description: "FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/breakthrough-device#term", "name": "Breakthrough Device Designation", "alternateName": "BDD", "description": "The Breakthrough Devices Program offers more interactive FDA communication, sprint discussions, and prioritized review for devices that provide more effective treatment or diagnosis of serious conditions and meet at least one additional criterion such as no approved alternatives.", "url": "https://medtechterms.com/terms/breakthrough-device", "termCode": "breakthrough-device", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/breakthrough-device#article", "headline": "BDD, Breakthrough Device Designation", "description": "FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions.", "url": "https://medtechterms.com/terms/breakthrough-device", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/breakthrough-device" }, "about": { "@id": "https://medtechterms.com/terms/breakthrough-device#term" }, "articleSection": "Regulatory", "inLanguage": "en", "keywords": "Breakthrough Device Designation, BDD, 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": "Breakthrough Devices Program", "url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program", "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/510k#term", "name": "510(k) Premarket Notification", "alternateName": "510(k)", "url": "https://medtechterms.com/terms/510k" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/pma#term", "name": "Premarket Approval", "alternateName": "PMA", "url": "https://medtechterms.com/terms/pma" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/de-novo#term", "name": "De Novo Classification Request", "alternateName": "De Novo", "url": "https://medtechterms.com/terms/de-novo" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/tcet#term", "name": "Transitional Coverage for Emerging Technologies", "alternateName": "TCET", "url": "https://medtechterms.com/terms/tcet" } ] }, { "@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": "Breakthrough Device Designation", "item": "https://medtechterms.com/terms/breakthrough-device" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/breakthrough-device#faq", "mainEntity": [ { "@type": "Question", "name": "What is the primary benefit of Breakthrough Device Designation?", "acceptedAnswer": { "@type": "Answer", "text": "The primary benefit is more interactive and timely communication with the FDA, including opportunities for sprint discussions and prioritized review, which can significantly shorten the time to market." } }, { "@type": "Question", "name": "Does Breakthrough Device Designation change the approval requirements?", "acceptedAnswer": { "@type": "Answer", "text": "No, it does not alter the statutory standards for marketing authorization, such as 510(k) clearance or PMA approval. The evidentiary bar remains the same." } }, { "@type": "Question", "name": "Can a device lose its Breakthrough Device Designation?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, a device can lose its designation if it no longer meets the qualifying criteria, for example, if a new alternative device becomes available that negates its 'significant advantage' claim." } }, { "@type": "Question", "name": "Is Breakthrough Device Designation available for all medical devices?", "acceptedAnswer": { "@type": "Answer", "text": "No, it is specifically for medical devices and device-led combination products that address life-threatening or irreversibly debilitating diseases or conditions and meet additional criteria as outlined in the FDA's guidance." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Breakthrough Device Designation [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Connected & Cyber-Physical Devices](/ecosystems/connected-devices)[Global Markets](/ecosystems/global-markets)BDD # Breakthrough Device Designation FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition The Breakthrough Devices Program offers more interactive FDA communication, sprint discussions, and prioritized review for devices that provide more effective treatment or diagnosis of serious conditions and meet at least one additional criterion such as no approved alternatives. What the regulation says The FDA's Breakthrough Devices Program, established under Section 515(d)(4) of the Federal Food, Drug, and Cosmetic Act, aims to expedite the development and review of certain medical devices and device-led combination products. This program is detailed in the FDA guidance document, "Breakthrough Devices Program Guidance for Industry and Food and Drug Administration Staff." Devices must provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, and meet specific criteria such as representing a breakthrough technology, having no approved or cleared alternatives, offering significant advantages over existing alternatives, or improving patient access. The program is distinct from Emergency Use Authorizations and is a voluntary program. ## What this means in practice Designation does not change the evidentiary standard for clearance or approval but typically shortens timelines and improves alignment. Breakthrough status can also support Medicare reimbursement under the [TCET](/terms/tcet) pathway. ## Examples - A novel AI-powered diagnostic device for early detection of pancreatic cancer, a condition with limited early detection options, receives Breakthrough Device Designation. - A new neurostimulation device designed to reduce severe, refractory epileptic seizures, where current treatments are ineffective, is granted Breakthrough Device Designation. - A minimally invasive surgical tool that significantly reduces recovery time and complications for a life-threatening cardiac condition, compared to existing open-heart surgery, qualifies for the program. Common pitfalls - • One common mistake is assuming that Breakthrough Device Designation lowers the evidentiary standards for marketing authorization, which it does not. - • Another pitfall is delaying engagement with the FDA until late in device development, missing opportunities for early feedback and program benefits. - • Misunderstanding the criteria for designation, particularly the "no approved or cleared alternatives" clause, can lead to wasted application efforts. - • Failing to maintain the breakthrough characteristics throughout the development process can result in loss of designation. - • Companies sometimes incorrectly believe that breakthrough designation guarantees Medicare reimbursement, rather than merely facilitating a pathway like TCET, which still requires its own application and review. ## Frequently asked questions What is the primary benefit of Breakthrough Device Designation? The primary benefit is more interactive and timely communication with the FDA, including opportunities for sprint discussions and prioritized review, which can significantly shorten the time to market. Does Breakthrough Device Designation change the approval requirements? Can a device lose its Breakthrough Device Designation? Is Breakthrough Device Designation available for all medical devices? ## Cross-references ### Used by Things that build on this term. - [ Transitional Coverage for Emerging Technologies(TCET) ](/terms/tcet) - [ New Technology Add-On Payment(NTAP) ](/terms/ntap) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory De Novo Classification Request(De Novo) Pathway to classify novel low- to moderate-risk devices that lack a predicate. ](/terms/de-novo)[ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory Premarket Approval(PMA) FDA's most stringent device marketing application, required for high-risk Class III devices. ](/terms/pma)[ Reimbursement Transitional Coverage for Emerging Technologies(TCET) CMS pathway providing time-limited Medicare coverage for FDA-designated Breakthrough Devices. ](/terms/tcet) ### De Novo & Breakthrough Pathways · From this learning path [ Regulatory Combination Product Product comprised of two or more regulated components - e.g., drug-device, biologic-device. ](/terms/combination-product?from=de-novo-and-breakthrough)[ Regulatory Indications for Use(IFU (statement)) Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate. ](/terms/indications-for-use?from=de-novo-and-breakthrough)[ Regulatory Intended Use The objective intent of the manufacturer regarding the use of the device. ](/terms/intended-use?from=de-novo-and-breakthrough)[ Commercialization Pre-Submission Meeting(Q-Sub) Formal FDA feedback request prior to a marketing or IDE submission. Adjacent lesson ](/terms/pre-submission?from=de-novo-and-breakthrough) ### Founder & Investor Primer · From this learning path [ Commercialization Freedom to Operate(FTO) Analysis of whether a product can be sold without infringing third-party IP. Adjacent lesson ](/terms/freedom-to-operate?from=founder-and-investor-primer)[ Investment & Finance Capitalization Table(Cap Table) Ledger of all securities issued by a company and who owns them. ](/terms/cap-table?from=founder-and-investor-primer)[ Investment & Finance Convertible Note Short-term debt that converts into equity at a future financing round. ](/terms/convertible-note?from=founder-and-investor-primer)[ Investment & Finance Due Diligence Investigation of a company before an investment, financing, or acquisition. ](/terms/due-diligence?from=founder-and-investor-primer) Cited by Where this term appears across MedTech Terms. Learning paths (2) - [De Novo & Breakthrough Pathways](/paths/de-novo-and-breakthrough)Lesson 2 of 11 - [Founder & Investor Primer](/paths/founder-and-investor-primer)Lesson 5 of 16 Ecosystems (3) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Connected & Cyber-Physical Devices](/ecosystems/connected-devices) - [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 Breakthrough Devices Program Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program) 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 BDD Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=breakthrough-device) Learn in 60 seconds Card Lesson Quiz FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions. - · Designation does not change the evidentiary standard for clearance or approval but typically shortens timelines and improves alignment. - · Breakthrough status can also support Medicare reimbursement under the TCET pathway. Remember this Watch out: One common mistake is assuming that Breakthrough Device Designation lowers the evidentiary standards for marketing authorization, which it does not. Related terms - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [Premarket Approval(PMA) ](/terms/pma) - [De Novo Classification Request(De Novo) ](/terms/de-novo) - [Transitional Coverage for Emerging Technologies(TCET) ](/terms/tcet) You may also need Auto-suggested from Regulatory and shared keywords. - [NMPA Innovative Medical Device Pathway ](/terms/nmpa-innovation) - [Safer Technologies Program(STeP) ](/terms/step) - [Accreditation Scheme for Conformity Assessment(ASCA) ](/terms/asca) - [Companion Diagnostic (IVDR)(CDx) ](/terms/ivdr-companion-diagnostic) - [Real-Time PMA Supplement Review ](/terms/pma-real-time-review) - [Refuse to Accept(RTA) ](/terms/rta) [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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