The U.S. is the world’s largest and most dynamic market for medical devices.
For many companies, especially startups and small-to-medium-sized manufacturers, approval of medical devices in the U.S. is a crucial step toward market entry or expansion. The U.S. system administered by the FDA (Food and Drug Administration) offers an innovation-friendly path through clear structures, predictable costs, and streamlined procedures.
With expert consultants at our offices in Florida and California, WQS Management Consultants provides in-depth knowledge of the U.S. healthcare market and comprehensive support, from classification through to the successful market entry of your product and beyond. We ensure legal certainty, assist with liability issues, and guarantee full compliance throughout the entire process. In addition, we provide logistical support and offer you a comprehensive concept.
Innovation-friendly, fast, and lucrative.
With transparent processes, predictable costs, and centralized procedures, the U.S. offers the largest market and the highest growth potential for your company.
If you want to grow, you need to have a presence here!
The right time is now!
Our strategic presence and specialized services provide a significant advantage as you enter the U.S. market and expand your business globally.
Take this step with us!
The approval of medical devices in the U.S. is handled centrally by the Food and Drug Administration (FDA) and is based on the Federal Food, Drug, and Cosmetic Act (FDC Act). The regulatory framework for this is a risk-based classification system that determines the appropriate approval pathway.
| Risk Class | Risk Niveau | Procedure |
|---|---|---|
| Class I | Low | Registration & General Controls (GMP per 21 CFR 820 / QMSR) |
| Class II | Moderate | 510(k) Premarket Registration: Demonstration of “Substantial Equivalence” to a reference device |
| Class III | High | Premarket Approval (PMA): Extensive Preclinical & Clinical Data Required |
U.S. manufacturers looking to enter the EU and EU manufacturers seeking to enter the U.S. market face the same fundamental question: How do the FDA and the MDR compare in practice? The procedures use similar terms (risk classes, conformity assessment, quality management) but refer to different requirements. The following table shows the key differences.
| Criterion | FDA (U.S.) | EU MDR 2017/745 |
|---|---|---|
| Regulatory Authority | Food and Drug Administration (FDA) | Decentralized: Notified Bodies, supervised by national authorities |
| Risk Classes | Class I, II, III | Class I, IIa, IIb, III |
| Class I Approval Process | Registration + General Controls (GMP per 21 CFR 820 / QMSR) | Self-certification by the manufacturer (except for sterile products and measuring devices) |
| Class II Approval Process | 510(k) Premarket Notification: Demonstration of substantial equivalence | Conformity assessment by a Notified Body (Classes IIa and IIb) |
| Class III Approval Process | Premarket Approval (PMA): full clinical trial required | Conformity Assessment by a Notified Body + consultation with the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) |
| Clinical Data | Class I: not required Class II: usually based on published literature Class III: clinical trial | Clinical evaluation mandatory for all classes (MDR Annex XIV, MEDDEV 2.7/1 Rev. 4) |
| Quality Management System | QMSR (21 CFR 820) to be aligned with ISO 13485 starting in 2026 | ISO 13485 (not legally required, but de facto standard) |
| Post-Market Surveillance | Medical Device Reporting, 21 CFR 803/806 | PMS plan, PSUR/PMSR, PMCF; mandatory for all classes (MDR Articles 83–86) |
| Registration Database | FDA 510(k) Database, GUDID | EUDAMED (mandatory as of May 26, 2026) |
| Authorized Representative | US Agent) (for foreign manufacturers) 21 CFR 807.40 | EU Authorized Representative (for non-EU manufacturers) MDR Art. 11 |
| Typical Processing Time | 510(k): 3–12 months PMA: 1–3 years | Class I: 3–6 months Class IIa–III: 12–36 months (depending on the Notified Body) |
| Validity of Approval & Recertification | Indefinite (provided there are no product changes) | Certificates are generally valid for 5 years |
| Innovation Support | Breakthrough Devices Program | No structured fast-track system |
| Labeling | FDA registration number, UDI (21 CFR 801) | CE Marking, UDI, EUDAMED registration (MDR Art. 10, Annex I) |
In vitro diagnostic medical devices are subject to different regulatory systems in the U.S. and the EU. The EU IVDR 2017/746 has significantly tightened the requirements compared to the previous directive (IVDD). U.S. manufacturers that already have FDA clearance can often use existing performance data for EU approval, provided it meets EU evidence standards.
| Criterion | FDA (U.S.) IVD | EU IVDR 2017/746 |
|---|---|---|
| Risk Classes | Class I, II, III (analogous to medical devices) | Class A, B, C, D (separate system per IVDR Annex VIII) |
| Approval for Class I / A | Registration + General Controls | Self-Certification (non-sterile Class A); Sterile Class A: Notified Body for sterilization aspects |
| Approval for Class II, III / B, C, D | 510(k) or PMA, depending on risk class and predicate | Conformity Assessment by a Notified Body is mandatory (Classes B, C, D) |
| Performance Evaluation | Analytical and Clinical Performance Studies (depending on class) | Performance Evaluation Plan + Performance Evaluation Report (IVDR Annex XIII) for all classes |
| Post-Market | Medical Device Reporting, 21 CFR 803 | Post-Market Performance Follow-Up (PMPF), mandatory under IVDR Art. 82 |
| Conformity Assessment Procedures | No direct equivalents | European Commission has the authority to publish Common Technical Specifications (CTS) for certain IVD categories (IVDR Art. 9) |
| Registration Database | FDA Database, GUDID | EUDAMED (mandatory starting in 2026) |
| Use of U.S. Data for the EU | — | U.S. performance data is acceptable provided that EU evidence standards are met (IVDR Annex XIII) |
Many manufacturers seek FDA approval and CE marking simultaneously. WQS coordinates both processes. With offices in Hamm (Germany) and St. Petersburg (Florida), we cover regulatory requirements on both sides of the Atlantic.
WQS provides reliable support throughout the entire approval process and beyond.
To help you successfully establish your innovations in the U.S. market, we’re here for you whenever you need us. Feel free to contact us directly.
Efficiency and predictability through:
Support for US companies to enter the European market. EU Rep, Certification, QM System, Technical Documentation, support of the Procedure, selection of a Notified Body, support of the Certification Procedure, preparation of a Clinical Evaluation, support of Clinical Studies, including the Logistical Concepts.
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