FDA Registration & Clearance
US market authorization for medical devices via the FDA's 510(k), De Novo, or PMA pathways.
Overview
What FDA 510(k) / PMA is and why it matters
The U.S. FDA regulates medical devices through a risk-based classification system (Class I, II, III). Most Class II devices reach market via a 510(k) premarket notification demonstrating substantial equivalence to an existing predicate device; novel devices without a predicate may use the De Novo pathway; higher-risk Class III devices generally require a Premarket Approval (PMA) supported by clinical data.
Requirements
What you'll need
- Device classification (Class I, II, III)
- FDA establishment registration and device listing
- 510(k) premarket notification for most Class II devices
- De Novo pathway for novel low-to-moderate-risk devices with no predicate
- PMA with clinical data for Class III devices
- Quality System Regulation / QMSR (21 CFR 820) compliance
- Labeling per 21 CFR 801
- Unique Device Identification (UDI) compliance
Typical timeline
3–36 months
510(k) submissions typically take 3–9 months from filing (excluding pre-submission preparation); PMA pathways with clinical trials can take 1–3 years.
Estimated cost
$10k–$500k
510(k) submissions (excluding testing) often run $10k–75k in consulting and FDA fees; PMA pathways with full clinical trials can reach into the millions.
Where this applies
Applicable countries
Related
Regulatory Pathways
FAQ
Frequently asked questions
What's the difference between 510(k) and PMA?+
510(k) demonstrates a new device is substantially equivalent to one already legally marketed; PMA requires independent clinical evidence of safety and effectiveness and applies mainly to Class III devices.
Do I need a US-based agent?+
Foreign establishments must designate a US Agent for FDA correspondence, though this differs from an EU-style Authorized Representative.
Related
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Export documentation confirming a product is legally sold in its country of origin — often required by importing countries.
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Reviewed launch planning
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