Learn how to launch a medical device in the US.

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.

Every foreign establishment must designate a US Agent - a US-resident individual or business - as FDA's communication channel. Pick one before you register.

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.

Free written FDA feedback in ~75 days on your proposed pathway, predicate, testing, and clinical strategy. Highest-leverage de-risk for any foreign manufacturer.

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.

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.

Free program - qualifies foreign manufacturers under $100M gross receipts for reduced FDA user fees. Approval letter is reusable across submissions for the fiscal year.

Required at import for radiation-emitting electronic devices (lasers, ultrasound, X-ray). Customs will hold your shipment without it.

Center for Devices and Radiological Health. Start here, then read the actual guidance documents - not third-party summaries.

Find your three-letter product code, regulation number, and device class. Determines pathway, special controls, and applicable guidance.

Search every cleared 510(k). Predicate identification, summary letters, and competitive intelligence in one free database.

FDA's QMS regulation. Harmonized with ISO 13485:2016 effective 2 Feb 2026. Foreign sites are subject to FDA inspection under Part 820.

International QMS standard. Conformance is now the path to QMSR conformance - invest in it before US entry, not after.

Risk management for medical devices. Maps directly into your design history file and cybersecurity risk register.

Software safety classification A/B/C and required activities per class. FDA recognizes the consensus standard with a Declaration of Conformity.

Free FDA-produced video tutorials on every submission pathway. Watch before your Pre-Sub meeting.

Mandatory cybersecurity content for premarket submissions of cyber devices under FD&C Act §524B. SBOM, threat model, postmarket plan.

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.

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.

NIH registry of clinical studies. Required registration for most US device trials - and the cheapest competitive intelligence in the industry.

The two largest US commercial IRBs. Faster than most academic IRBs for industry-sponsored device studies.

National Coverage Determinations, Local Coverage Determinations, and the TCET pathway for Breakthrough Devices. Your trial endpoints should map to these before you enroll.

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.

Trade-association policy briefs on coding, coverage, and payment. The plain-English layer over CMS rule-making.

FDA's framework for using RWE in regulatory decisions. Increasingly accepted for label expansions and post-approval studies on cleared devices.

Curated US and US-active MedTech VCs, strategics, and family offices. Filter by stage, geography, and check size.

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.

Standard US holding-company structure for foreign founders raising US venture capital. Most US investors will not invest into a foreign parent.

World's largest non-dilutive accelerator for MedTech. 4-month curriculum, 750+ alumni, $7M+ awarded annually. Equity-free.

$500K standard deal, US-incorporated. Strong network for non-US founders relocating to the Bay Area.

Mayo Clinic, Cedars-Sinai, UnitedHealthcare programs. Strong US hospital channel access for pilot deployment.

No-strings lab residencies in 13 cities (10 US locations). Excellent landing pad for hardware founders relocating R&D into the US.

Up to $1.5M non-dilutive for US-Israeli MedTech joint projects. Underused channel for cross-border R&D entering the US market.

Stage-and-device-aware estimate of your FDA §524B cybersecurity spend. Outputs a one-page worksheet PDF.

Slide-by-slide analysis of what US MedTech investors actually want on each page. Adapted from 100+ decks.

510(k) vs De Novo vs PMA decision tree, mapped to predicate strategy and US clinical evidence burden.

Plain-English definitions for the FDA, CMS, clinical, cybersecurity, and funding terminology a foreign founder will hit on day one.

Stage-by-stage map of what to build, hire, certify, and raise from idea to US commercial launch.

Failure-mode taxonomy with public post-mortems and the regulatory/commercial signals that preceded each.

IDN selling motion, GPO contracting, KOL recruitment, and the chasm between early adopter clinicians and procurement.

Live FDA clearances, recalls, CISA medical device advisories, ClinicalTrials.gov updates, and funding rounds. Updated daily.