--- title: "MedTech Launch Guide - US Market Education Hub" description: "Plain-English education hub for medtech founders: 7-stage roadmap, FDA pathways, CMS reimbursement, cyber and a live Pulse of clearances and funding." lang: en json-ld: | { "@context": "https://schema.org", "@type": "CollectionPage", "name": "MedTech Launch Guide - Education Hub for MedTech Innovators", "description": "Education hub for medtech innovators bringing a device into the US market. Founder roadmap (IP, FDA pathway, clinical, reimbursement, cybersecurity, business model, GTM), curated FDA/CMS/NIH/CISA resources, and a live pulse of clearances, recalls and funding.", "url": "https://medtechlaunchguide.com", "publisher": { "@type": "Organization", "name": "MedTech Launch Guide", "url": "https://medtechlaunchguide.com" }, "hasPart": [ { "@type": "ItemList", "name": "US Market Entry", "description": "The legal, corporate, and FDA-facing infrastructure a non-US manufacturer needs in place before a single unit ships into the United States.", "numberOfItems": 8 }, { "@type": "ItemList", "name": "FDA Regulation & Quality", "description": "The CDRH guidance documents, quality system regulation, and standards your US submission and inspections will be measured against.", "numberOfItems": 9 }, { "@type": "ItemList", "name": "US Clinical Evidence & Reimbursement", "description": "How to generate the evidence FDA expects - and the CMS / CPT pathway that determines whether US clearance translates into a US business.", "numberOfItems": 8 }, { "@type": "ItemList", "name": "US Funding & Non-Dilutive Capital", "description": "US investors, US accelerators, and the federal grant programs that will fund a foreign-founded company once you incorporate a US entity.", "numberOfItems": 8 }, { "@type": "ItemList", "name": "Templates, Tools & Calculators", "description": "Worksheets and editorial deep-dives produced by MedTech Launch Guide for founders preparing a US submission. Free, no email-wall.", "numberOfItems": 8 } ] } --- [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 Education hub · US market · Updated weekly # Learn how to launch a _medical device_ in the US. The plain-English education hub for medtech innovators. Start with the seven-stage Founder Roadmap - IP, FDA pathway, clinical evidence, reimbursement, cybersecurity, business model, GTM - then dig into curated resources from FDA, CMS, NIH and CISA. A live Pulse of clearances, recalls and funding rounds runs alongside. [Start here - build my plan](/start)[Full roadmap](/roadmap)[Live Pulse](/pulse) [ Founder Roadmap 7 stages · IP → GTM, end to end Open roadmap → ](/roadmap)[ Live Pulse FDA · CISA · Trials · Rounds Open feed → ](/pulse)[ Investors US-active MedTech firms Browse → ](/investors) 00 - Start here ## The Founder Roadmap Seven workstreams every US-bound medical device company runs in parallel. Each stage is a self-contained lesson - what to build, what to ship, what to budget, what kills founders here. Not sure where to begin? Start with stage 00. 1. [ Stage 00 ### Start Here Three questions, then a plan ordered for your device and stage Build my plan ](/start) 2. [ Stage 01 ### IP Protection File before you publish, demo, or pitch a stranger Open lesson ](/roadmap/ip-protection) 3. [ Stage 02 ### Regulatory Pathway 510(k), De Novo, or PMA - and the Pre-Sub that de-risks each Open lesson ](/roadmap/regulatory-pathway) 4. [ Stage 03 ### Clinical Evidence IDE, IRB, ClinicalTrials.gov - generate the data FDA and CMS both want Open lesson ](/roadmap/clinical-evidence) 5. [ Stage 04 ### Reimbursement Coding, coverage, payment - the three legs every payer requires Open lesson ](/roadmap/reimbursement) 6. [ Stage 05 ### Cybersecurity FD&C Act Section 524B - premarket package + lifelong postmarket plan Open lesson ](/roadmap/cybersecurity) 7. [ Stage 06 ### Business Model Capital equipment, consumables, SaaS, or service - pick on purpose Open lesson ](/roadmap/business-model) 8. [ Stage 07 ### Go-To-Market KOLs, IDN selling, GPO contracting, and the chasm in between Open lesson ](/roadmap/go-to-market) 9. [See the full roadmap with cost, duration, artifacts and pitfalls ](/roadmap) Resource library ## Curated reading by topic Five sections, each one a vetted shortlist. Primary-source FDA, CMS, NIH and CISA links - no SEO filler, no email walls. [US Market Entry](#us-entry)[FDA Regulation & Quality](#regulatory)[US Clinical Evidence & Reimbursement](#clinical)[US Funding & Non-Dilutive Capital](#funding)[Templates, Tools & Calculators](#templates) 01 - US Market Entry ## US Market Entry The legal, corporate, and FDA-facing infrastructure a non-US manufacturer needs in place before a single unit ships into the United States. [ ### FDA Establishment Registration & Device Listing USA · Mandatory Annual registration of every facility that manufactures, repackages, relabels, or imports devices for the US market - plus device listing in FURLS. Required before US distribution. ](https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing)[ ### US Agent for Foreign Establishments USA · Foreign mfr Every foreign establishment must designate a US Agent - a US-resident individual or business - as FDA's communication channel. Pick one before you register. ](https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing)[ ### 510(k), De Novo, or PMA - Pathway Selection USA · Pathway Choosing the wrong pathway is the most expensive mistake in US entry. Search the 510(k) database for predicates first; if none, plan for De Novo or PMA. ](https://www.fda.gov/medical-devices/how-study-and-market-your-device/premarket-submissions-selecting-and-preparing-correct-submission)[ ### FDA Pre-Submission (Q-Sub) Program USA · Free Free written FDA feedback in ~75 days on your proposed pathway, predicate, testing, and clinical strategy. Highest-leverage de-risk for any foreign manufacturer. ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program)[ ### Refuse to Accept (RTA) Checklist USA · Checklist FDA's administrative completeness checklist. Your 510(k) gets bounced in 15 days if any item is missing - read this before you submit, not after. ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks)[ ### Medical Device User Fee Amendments (MDUFA) USA · Fees Annual fee schedule for 510(k), De Novo, PMA, and registration. Small Business Determination can drop most fees by 50–75% - apply before your first submission. ](https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa)[ ### FDA Small Business Determination (SBD) USA · Free Free program - qualifies foreign manufacturers under $100M gross receipts for reduced FDA user fees. Approval letter is reusable across submissions for the fiscal year. ](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/reduced-or-waived-medical-device-user-fees-small-business-determination-sbd-program)[ ### Form FDA 2877 - Electronic Product Import USA · Import Required at import for radiation-emitting electronic devices (lasers, ultrasound, X-ray). Customs will hold your shipment without it. ](https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices) 02 - FDA Regulation & Quality ## FDA Regulation & Quality The CDRH guidance documents, quality system regulation, and standards your US submission and inspections will be measured against. [ ### FDA CDRH - Devices Home USA · Regulator Center for Devices and Radiological Health. Start here, then read the actual guidance documents - not third-party summaries. ](https://www.fda.gov/medical-devices)[ ### FDA Product Classification Database USA · Database Find your three-letter product code, regulation number, and device class. Determines pathway, special controls, and applicable guidance. ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm)[ ### FDA 510(k) Premarket Notification Database USA · Database Search every cleared 510(k). Predicate identification, summary letters, and competitive intelligence in one free database. ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)[ ### Quality Management System Regulation (QMSR) - 21 CFR 820 USA · Regulation FDA's QMS regulation. Harmonized with ISO 13485:2016 since 2 Feb 2026. Foreign sites are subject to FDA inspection under Part 820. ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820)[ ### ISO 13485:2016 - Medical Device QMS Standard International QMS standard. Conformance is now the path to QMSR conformance - invest in it before US entry, not after. ](https://www.iso.org/iso-13485-medical-devices.html)[ ### ISO 14971 - Risk Management Standard Risk management for medical devices. Maps directly into your design history file and cybersecurity risk register. ](https://www.iso.org/standard/72704.html)[ ### IEC 62304 - Medical Device Software Lifecycle Standard Software safety classification A/B/C and required activities per class. FDA recognizes the consensus standard with a Declaration of Conformity. ](https://www.iso.org/standard/38421.html)[ ### FDA CDRH Learn (free courses) Free · Video Free FDA-produced video tutorials on every submission pathway. Watch before your Pre-Sub meeting. ](https://www.fda.gov/training-and-continuing-education/cdrh-learn)[ ### FDA Cybersecurity in Medical Devices: QMS Considerations (3 Feb 2026) USA · Premarket Mandatory cybersecurity content for premarket submissions of cyber devices under FD&C Act Section 524B. SBOM, threat model, postmarket plan. ](https://www.fda.gov/media/119933/download) 03 - US Clinical Evidence & Reimbursement ## US Clinical Evidence & Reimbursement How to generate the evidence FDA expects - and the CMS / CPT pathway that determines whether US clearance translates into a US business. [ ### FDA IDE - Investigational Device Exemption USA · Pathway Required to legally study a not-yet-cleared significant-risk device in US patients. Foreign data can support a 510(k) but rarely a PMA without US enrollment. ](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide)[ ### FDA Acceptance of Foreign Clinical Data USA · Guidance What FDA will and won't accept from clinical studies run outside the US. Read this before you spend on a non-US trial expecting it to do double duty. ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-clinical-data-support-medical-device-applications-and-submissions-frequently-asked)[ ### ClinicalTrials.gov USA · Registry NIH registry of clinical studies. Required registration for most US device trials - and the cheapest competitive intelligence in the industry. ](https://clinicaltrials.gov/)[ ### WCG IRB / Advarra (commercial IRBs) USA · IRB The two largest US commercial IRBs. Faster than most academic IRBs for industry-sponsored device studies. ](https://www.wcgclinical.com/)[ ### CMS - Coverage Resources USA · Payer National Coverage Determinations, Local Coverage Determinations, and the TCET pathway for Breakthrough Devices. Your trial endpoints should map to these before you enroll. ](https://www.cms.gov/medicare/coverage/center)[ ### AMA CPT Code Application USA · Coding How to apply for a Category I or III CPT code. Plan 18–36 months ahead of US commercial launch - no code, no predictable reimbursement. ](https://www.ama-assn.org/practice-management/cpt/applying-cpt-codes)[ ### AdvaMed - Reimbursement Resources USA · Trade body Trade-association policy briefs on coding, coverage, and payment. The plain-English layer over CMS rule-making. ](https://www.advamed.org/issues/payment/)[ ### FDA Real-World Evidence Program USA · Guidance FDA's framework for using RWE in regulatory decisions. Increasingly accepted for label expansions and post-approval studies on cleared devices. ](https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence) 04 - US Funding & Non-Dilutive Capital ## US Funding & Non-Dilutive Capital US investors, US accelerators, and the federal grant programs that will fund a foreign-founded company once you incorporate a US entity. [ ### MedTech Investor Directory Internal · Curated Curated US and US-active MedTech VCs, strategics, and family offices. Filter by stage, geography, and check size. ](/investors)[ ### NIH SBIR / STTR USA · Non-dilutive Up to $2M+ non-dilutive across Phase I/II for US small businesses. NIH is the largest SBIR funder for medical devices. Requires a US C-corp and >50% US ownership for some sub-programs. ](https://seed.nih.gov/small-business-funding/small-business-program-basics/understanding-sbir-sttr)[ ### Delaware C-Corp Formation (Stripe Atlas / Clerky) USA · Incorporation Standard US holding-company structure for foreign founders raising US venture capital. Most US investors will not invest into a foreign parent. ](https://stripe.com/atlas)[ ### MedTech Innovator (Global) US-run · Equity-free World's largest non-dilutive accelerator for MedTech. 4-month curriculum, 750+ alumni, $7M+ awarded annually. Equity-free. ](https://medtechinnovator.org/)[ ### Y Combinator (Healthcare) US · 7% equity $500K standard deal, US-incorporated. Strong network for non-US founders relocating to the Bay Area. ](https://www.ycombinator.com/companies?industry=Healthcare)[ ### Techstars Healthcare US · 6% · $120K Mayo Clinic, Cedars-Sinai, UnitedHealthcare programs. Strong US hospital channel access for pilot deployment. ](https://www.techstars.com/accelerators)[ ### JLABS (J&J Innovation) US-heavy · Lab access No-strings lab residencies in 13 cities (10 US locations). Excellent landing pad for hardware founders relocating R&D into the US. ](https://jnjinnovation.com/jlabs)[ ### BIRD Foundation (US-Israel) US-IL · Non-dilutive Up to $1.5M non-dilutive for US-Israeli MedTech joint projects. Underused channel for cross-border R&D entering the US market. ](https://www.birdf.com/) 05 - Templates, Tools & Calculators ## Templates, Tools & Calculators Worksheets and editorial deep-dives produced by MedTech Launch Guide for founders preparing a US submission. Free, no email-wall. [ ### Cybersecurity Budget Calculator Tool · Free Stage-and-device-aware estimate of your FDA Section 524B cybersecurity spend. Outputs a one-page worksheet PDF. ](/pulse#cyber)[ ### Pitch Deck Teardown Editorial Slide-by-slide analysis of what US MedTech investors actually want on each page. Adapted from 100+ decks. ](/pulse#pitch)[ ### Regulatory Pathway Selector Tool 510(k) vs De Novo vs PMA decision tree, mapped to predicate strategy and US clinical evidence burden. ](/pulse#regulatory)[ ### MedTech Glossary Reference Plain-English definitions for the FDA, CMS, clinical, cybersecurity, and funding terminology a foreign founder will hit on day one. ](/glossary)[ ### Founder Journey Map Editorial Stage-by-stage map of what to build, hire, certify, and raise from idea to US commercial launch. ](/pulse#journey)[ ### Why MedTech Startups Fail Editorial Failure-mode taxonomy with public post-mortems and the regulatory/commercial signals that preceded each. ](/pulse#failure)[ ### GTM Playbook (US hospital channel) Editorial IDN selling motion, GPO contracting, KOL recruitment, and the chasm between early adopter clinicians and procurement. ](/pulse#playbook)[ ### Live MedTech Pulse Live data Live FDA clearances, recalls, CISA medical device advisories, ClinicalTrials.gov updates, and funding rounds. 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