{"paper_id":"2d76ecdb-8edb-4197-bd41-24f8a8a72574","body_text":"Competitive Value of Acquiring Novel FDA Product Codes for Medical Device Manufacturers An Original Investigation | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article Competitive Value of Acquiring Novel FDA Product Codes for Medical Device Manufacturers An Original Investigation Karl L. Schumacher, Paul-Elie Nauleau, Prashanth Asuri This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6754717/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 10 You are reading this latest preprint version Abstract The FDA classifies medical devices by risk, assigning each a Product Code (PC) that determines its regulatory pathway for clearance. Novel PCs are created when new technologies raise safety or efficacy questions not addressed by existing codes. This analysis examines whether novel PCs provide strategic or regulatory advantages to first-mover manufacturers and how PC use evolves. Using FDA clearance data from 2000-2024, we analyzed the origin, usage patterns, and review timelines of novel PCs across filing types and medical specialties. We find that initial filers of novel PCs often experience longer time intervals before that PCs reuse, suggesting a period of de facto exclusivity. Traditional 510(k), PMA, and Post-NSE DeNovo filings are linked to longer exclusivity, while Direct DeNovo filings, despite producing the most novel PCs, offer less exclusivity and longer review times. These trends indicate acquiring novel PCs may benefit manufacturers across risk classes and medical specialty. Business and commerce/Operational research Social science/Social policy Full Text Additional Declarations Competing interest reported. The authors declare the following potential conflicts of interest: author PN is employed by Inquis Medical, a medical device manufacturer. These affiliations had no involvement in the design, analysis, interpretation, or publication of this analysis. KS and PA declare no competing interests. Supplementary Files npjSubmissionSupplementalMaterial.pdf Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Revision requested 20 Jun, 2025 Reviews received at journal 20 Jun, 2025 Reviewers agreed at journal 01 Jun, 2025 Reviewers agreed at journal 31 May, 2025 Reviews received at journal 31 May, 2025 Reviewers agreed at journal 31 May, 2025 Reviewers invited by journal 29 May, 2025 Editor assigned by journal 29 May, 2025 Submission checks completed at journal 27 May, 2025 First submitted to journal 26 May, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {\"props\":{\"pageProps\":{\"initialData\":{\"identity\":\"rs-6754717\",\"acceptedTermsAndConditions\":true,\"allowDirectSubmit\":false,\"archivedVersions\":[],\"articleType\":\"Article\",\"associatedPublications\":[],\"authors\":[{\"id\":464913701,\"identity\":\"ce4cbd8c-2a02-47db-9f2b-20276dc4ef2b\",\"order_by\":0,\"name\":\"Karl L. 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The authors declare the following potential conflicts of interest: author PN is employed by Inquis Medical, a medical device manufacturer. These affiliations had no involvement in the design, analysis, interpretation, or publication of this analysis. 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