Regulatory strategy
Initial assessment, device classification and development of the full approval roadmap in the country.
FDA
Register your medical device in the United States.
Register medical devices in the United States through 510(k), PMA or De Novo, with an English-language technical dossier and a dedicated U.S. Agent.
Speak to a specialistThe authority
U.S. Food and Drug Administration
FDA
Since 1906
United States
A federal agency within the Department of Health and Human Services responsible for protecting public health by ensuring the safety and efficacy of medicines, food and medical devices.
Visit the official websiteRegulatory framework
Main legislation and risk classes
| Class | Description | Examples |
|---|---|---|
| Class I | Low risk, general controls | Surgical gloves, gauze, stethoscopes |
| Class II | Moderate risk, generally requiring 510(k) | Infusion pumps, external pacemakers, X-ray equipment |
| Class III | High risk, requiring PMA and clinical studies | Heart valves, breast implants, internal pacemakers |
Registration process
How we manage your project
- 01
Classification1-2 weeks
Determine the risk class (I, II or III) using the FDA product code
- 02
QMS implemented3-6 months
Quality management system compliant with 21 CFR Part 820 (QMSR in 2026)
- 03
Technical dossier2-4 months
Prepare the 510(k), PMA or De Novo submission using the eSTAR electronic template
- 04
U.S. Agent1 week
Appoint a representative in the USA (mandatory for foreign manufacturers)
- 05
FDA reviewvariable
510(k): 30-90 days for official review. PMA: 180 statutory days, in practice 9-36 months
- 06
Establishment Registration1 week
Register the establishment with the FDA and complete annual device listing
Total timeframe6-9 months for Class II via 510(k); 12-36 months for Class III via PMA
Local representativeU.S. Agent
Approximate costUSD 10k-50k in FDA fees plus consultancy
Post-market
Post-approval obligations
| Area | Requirement |
|---|---|
| Surveillance | MDR reporting through the FDA MAUDE database for adverse events and malfunctions |
| Renewal | Indefinite registration plus paid annual Establishment Registration |
| Required QMS | 21 CFR Part 820 (QMSR from February 2026, harmonising with ISO 13485) |
How HSC helps
Your company ready for FDA registration in 6 to 9 months.
Technical dossier
Document preparation and translation in accordance with local requirements, including responses to deficiencies and requests.
Local representation
Acting directly as legal representative or recommending an authorised partner accredited by the authority.
Ongoing post-market support
Monitoring regulatory changes, renewals, surveillance and responses to authority audits.
Frequently asked questions
Questions about FDA
Next step
Ready to start your project in the United States?
Speak to our team for an initial assessment of your product and the most efficient regulatory pathway.
Speak to a specialist