--- title: "Clinical Evidence - MedTech Roadmap | MedTech Launch Guide" description: "IDE, IRB, ClinicalTrials.gov - generate the data FDA and CMS both want. Most 510(k)s do not require a clinical study; most De Novos and all PMAs do. Even if F" lang: en json-ld: | { "@context": "https://schema.org", "@type": "Article", "headline": "Clinical Evidence - MedTech Roadmap", "description": "Most 510(k)s do not require a clinical study; most De Novos and all PMAs do. Even if FDA doesn't require evidence, CMS will - design the trial endpoints to satisfy both regulators and payers in a single study. Foreign data can support a 510(k) but rarely a PMA without US enrollment.", "url": "https://medtechlaunchguide.com/roadmap/clinical-evidence", "mainEntityOfPage": "https://medtechlaunchguide.com/roadmap/clinical-evidence", "articleSection": "Clinical Evidence", "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 03 of 7 · Roadmap # Clinical Evidence IDE, IRB, ClinicalTrials.gov - generate the data FDA and CMS both want When to start After Pre-Sub feedback confirms the evidence burden Duration Feasibility: 6–12 months · Pivotal: 12–36 months Indicative cost USD 250K (small feasibility) → 5M+ (pivotal IDE) Most 510(k)s do not require a clinical study; most De Novos and all PMAs do. Even if FDA doesn't require evidence, CMS will - design the trial endpoints to satisfy both regulators and payers in a single study. Foreign data can support a 510(k) but rarely a PMA without US enrollment. ## Significant-risk vs non-significant-risk If the study presents serious risk to subjects, you need an FDA IDE before enrolling. Non-significant-risk studies follow abbreviated IDE requirements with IRB approval only. Get the SR/NSR determination wrong and you've conducted an unauthorized clinical investigation. ## Design endpoints for FDA + CMS in one study FDA cares about safety and effectiveness vs the predicate. CMS cares about clinically meaningful outcomes vs current standard of care. A trial designed only for FDA often fails to support a coverage decision later - costing 2–4 years and another trial. ## Site and IRB selection Commercial IRBs (WCG, Advarra) approve in weeks; academic IRBs can take months. Pick sites with prior IDE experience for your indication - they have established workflows for FDA reporting requirements. Artifacts to ship - Clinical Investigation Plan (protocol) - IDE submission (if SR) + FDA approval letter - IRB approval at every site - ClinicalTrials.gov registration (NCT number) - Statistical analysis plan + final clinical study report Common pitfalls - Designing the study only for FDA, then re-running it for CMS - Underpowering the study to save cost - then failing the primary endpoint by a margin smaller than n=20 would have closed - Foreign-only data on a PMA - FDA almost always requests US bridging study - Skipping ClinicalTrials.gov registration (it's a federal mandate) Primary sources - [FDA IDE Overview Pathway ](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide) - [ClinicalTrials.gov Required registration ](https://clinicaltrials.gov/) - [FDA SR/NSR Determination Guidance ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/significant-risk-and-nonsignificant-risk-medical-device-studies) - [FDA Acceptance of Foreign Clinical Data Foreign data ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-clinical-data-support-medical-device-applications-and-submissions-frequently-asked) [ Previous Regulatory Pathway Step 02 · 510(k), De Novo, or PMA - and the Pre-Sub that de-risks each ](/roadmap/regulatory-pathway)[ Next Reimbursement Step 04 · Coding, coverage, payment - the three legs every payer requires ](/roadmap/reimbursement) 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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