Regulatory Approval for Medical Devices in the U.S.

Successfully Entering the U.S. Market with FDA 510(k) & More

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.

Why the U.S. Market?

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!

We know the Path!

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!

Regulatory Framework for Medical Devices in the U.S.

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 Classes and Approval Pathways

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

Special Procedures for Innovative Products

Breakthrough Device Program:
Through the Breakthrough Devices Program, the FDA offers an expedited approval process for products with significant medical benefits, such as those intended for life-threatening or irreversibly debilitating conditions.
De Novo Procedure:
The De Novo procedure is intended for manufacturers of medical devices that are novel and pose a risk, do not correspond to any existing product (predicate device), but are still classified below Risk Class III.

FDA Procedures Compared to the MDR and CE Marking

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)

FDA vs. EU IVDR Regulation

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)

Approval in Both Markets

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.

Market Access USA • FDA

Ready for the U.S. Market?

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.

Potential of the U.S. Approval System

Efficiency and predictability through:

Shorter procedures: 510(k) on average 3–9 months
Single point of contact centrally managed by the FDA
Public and transparent fee structure
No recertification required (provided there are no product changes)
Faster time to market due to reduced clinical data requirements in the 510(k)
Lower initial costs and fee reductions for small and medium-sized enterprises

Frequently Asked Questions about U.S. Approval

Regulatpry Approval for Medical Devices in the U.S.

How long does a 510(k) clearance take?

A 510(k) submission takes 3 to 12 months on average, depending on product complexity. Class III devices going through PMA require significantly more time: 1 to 3 years.

Can I use my CE marking for FDA clearance?

No. The FDA does not accept CE marking as proof of approval. Both systems require separate procedures, although some technical data, such as test reports, can be reused. Manufacturers targeting both markets plan for two distinct procedures from the start.

Do I need a US Agent as a foreign manufacturer?

Yes. Foreign manufacturers must designate a US Agent for FDA registration under 21 CFR 807.40. The US Agent is the FDA’s point of contact in the country.

What is the difference between 510(k) and PMA?

510(k) applies to Class II devices and requires demonstrating substantial equivalence to an already-cleared predicate device. PMA applies to Class III devices and requires extensive preclinical and clinical data.

Do I need a clinical trial for the U.S. market?

It depends on the class. Class I generally requires no clinical data, Class II usually relies on published literature, and Class III requires a dedicated clinical trial. The EU, by contrast, requires a clinical evaluation for all classes under MDR Annex XIV.

What changes in 2026 under the QMSR?

The FDA is aligning its quality management system under 21 CFR 820 (QMSR) with ISO 13485 starting in 2026. Manufacturers already ISO 13485-certified have an advantage, but this does not automatically satisfy QMSR compliance.

What does FDA approval cost?

The FDA publishes its fee structure openly, with reductions available for small and medium-sized businesses. Actual costs depend on product class and procedure. Flat figures without product context aren’t credible.

This page provides regulatory information and does not constitute legal advice. Regulatory requirements vary by jurisdiction.