United States
The United States is the largest and most competitive medical device market, with high standards and strong innovation. The U.S. market is worth over $180 billion and continues to grow due to population aging, technological advancements, and the expansion of telemedicine.
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Regulatory Framework
The competent authority is the Food and Drug Administration (FDA).
Device Classification:
- Class I: Low risk (e.g., basic surgical instruments)
- Class II: Moderate risk (e.g., syringes, non-invasive diagnostic devices)
- Class III: High risk (e.g., pacemakers, cardiovascular implants)
Main Regulatory Pathways
- 510(k): For devices substantially equivalent to products already on the market.
- PMA (Premarket Approval): For high-risk Class III devices, requiring comprehensive clinical data.
- De Novo: For innovative devices without existing approved equivalents.
Specific Local Requirements
| Language | Documentation in English. |
| Local Representative (US Agent) | Required for non-U.S. manufacturers. |
| Audits | FDA may inspect both U.S. and foreign manufacturing facilities.
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| Quality System Regulation (QSR) | U.S.-specific quality management regulations, similar to ISO 13485 but with distinct requirements. |
| Establishment Registration and Device Listing | Mandatory for importing medical devices into the U.S. |
Challenges and Operational Advice
- Market structure: Highly competitive; product differentiation is essential.
- Strict compliance: Must meet FDA regulations, including QSR, specific labeling, and post-market surveillance.
- Timelines: PMA procedures can take up to 18 months; even 510(k) submissions often require additional information.
- Importance of Clinical Trials: For high-risk devices, planning FDA-compliant clinical studies is crucial.
Why Choose ISEMED
- FDA Expertise
Consulting on 510(k), PMA, De Novo, and FDA registrations. - Regulatory Support
Assistance with audits, documentation, and managing FDA inquiries. - Clinical Trial Management
Support for planning and conducting clinical studies for Class III devices.
FAQ
- Is a local representative required? Yes, a US Agent for foreign manufacturers.
- Documentation language? English.
- Authorization duration? Unlimited, subject to post-market surveillance.
- How does 510(k) work? Demonstrates substantial equivalence to a previously approved device to avoid PMA.
- What is De Novo? A streamlined pathway for novel devices without an equivalent, less burdensome than PMA.