--- title: "Regulatory Pathway - MedTech Roadmap | MedTech Launch Guide" description: "510(k), De Novo, or PMA - and the Pre-Sub that de-risks each. Pathway selection determines your timeline, capital needs, and exit comparables. Search the FDA" lang: en json-ld: | { "@context": "https://schema.org", "@type": "Article", "headline": "Regulatory Pathway - MedTech Roadmap", "description": "Pathway selection determines your timeline, capital needs, and exit comparables. Search the FDA classification database for your three-letter product code first; if a predicate exists, you're likely 510(k). If none exists, you're De Novo. If your device is high-risk Class III, you're PMA - plan for clinical trials and a multi-year timeline.", "url": "https://medtechlaunchguide.com/roadmap/regulatory-pathway", "mainEntityOfPage": "https://medtechlaunchguide.com/roadmap/regulatory-pathway", "articleSection": "Regulatory Pathway", "isPartOf": { "@type": "CollectionPage", "name": "MedTech Founder Roadmap", "url": "https://medtechlaunchguide.com/roadmap" }, "publisher": { "@type": "Organization", "name": "MedTech Launch Guide", "url": "https://medtechlaunchguide.com" } } --- [Skip to content](#main) [ MedTech Launch Guide Education Hub for Founders ](/) [Roadmap](/roadmap) [Topics](/topics) Tools [Pulse](/pulse)Search ⌘K[Start Here](/start) Search ⌘K [Roadmap](/roadmap)/ [01 · IP Protection](/roadmap/ip-protection)[02 · Regulatory Pathway](/roadmap/regulatory-pathway)[03 · Clinical Evidence](/roadmap/clinical-evidence)[04 · Reimbursement](/roadmap/reimbursement)[05 · Cybersecurity](/roadmap/cybersecurity)[06 · Business Model](/roadmap/business-model)[07 · Go-To-Market](/roadmap/go-to-market) Step 02 of 7 · Roadmap # Regulatory Pathway 510(k), De Novo, or PMA - and the Pre-Sub that de-risks each When to start After a working prototype + intended use statement; before any clinical study Duration 510(k): 6–12 months FDA review · De Novo: 9–15 months · PMA: 18–36+ months Indicative cost USD 50K–200K (510(k)) · 200K–600K (De Novo) · 1M–10M+ (PMA) Pathway selection determines your timeline, capital needs, and exit comparables. Search the FDA classification database for your three-letter product code first; if a predicate exists, you're likely 510(k). If none exists, you're De Novo. If your device is high-risk Class III, you're PMA - plan for clinical trials and a multi-year timeline. ## Decision tree Three questions in order: Is there a legally marketed predicate device with the same intended use and technological characteristics? If yes → 510(k). If no, is the risk low-to-moderate? If yes → De Novo. If high-risk Class III → PMA. ## Use the Pre-Sub program The single highest-ROI step in your entire program. FDA returns written feedback in ~75 days on your proposed pathway, predicate, performance testing, and clinical strategy - for free. Founders who skip Pre-Sub typically pay 3–10× the cost in re-testing. ## Pass the RTA gate Refuse to Accept (RTA) is FDA's 15-day administrative completeness check. A submission that fails RTA is bounced before substantive review. Run your package against the RTA checklist line-by-line before you pay the user fee. Artifacts to ship - Product classification analysis with three-letter code - Predicate identification and substantial-equivalence rationale - Pre-Sub package + FDA written feedback letter - Verification & validation test reports - Software documentation per IEC 62304 - 510(k) / De Novo / PMA submission package Common pitfalls - Picking the most-cleared predicate instead of the most-defensible one - Skipping Pre-Sub to 'save 90 days' - and then re-testing for 12 months - Filing under 510(k) when the indication is genuinely novel (FDA will down-classify or punt to De Novo) - Underestimating software documentation burden under IEC 62304 Primary sources - [FDA Product Classification Database Find your code ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm) - [FDA 510(k) Database Predicate search ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) - [FDA Pre-Sub (Q-Sub) Program Free feedback ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program) - [FDA RTA Checklist (510(k)) Pre-flight ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks) [ Previous IP Protection Step 01 · File before you publish, demo, or pitch a stranger ](/roadmap/ip-protection)[ Next Clinical Evidence Step 03 · IDE, IRB, ClinicalTrials.gov - generate the data FDA and CMS both want ](/roadmap/clinical-evidence) MedTech Launch Guide The independent education hub for medtech innovators bringing devices to the US market - paired with a live pulse of what FDA, CMS, CISA and investors are doing right now. 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