US Market Access

No. CE Marking according to the MDR applies exclusively to the European market and is not recognized by the FDA. A separate approval procedure is required for the US market – 510(k) Submission Process, De Novo Submission Process, or Premarket Approval, depending on the product and Risk Class. However, much of the evidence from the EU can be used as supporting documentation, provided they meet FDA requirements. This saves time and costs – if planned correctly from the start.

All three are FDA pathways to US market – but for different products. The 510(k) Submission Process is the most common pathway for products that are substantially equivalent to an already cleared product. The De Novo Submission Process applies to novel products with low to moderate risk for which no equivalent device exists. Premarket Approval is the most demanding procedure – for high-risk Class III products requiring extensive clinical evidence. The decision on which pathway is right for you depends on your product, your data situation, and your market strategy.

No. FDA market approval/clearance and actual market access are not the same. Access to the US market may additionally depend on whether reimbursement options exist for the product. Therefore, the US market should not be viewed solely from a submission perspective, but also with regard to future economic viability, distribution model, and market presence.

Not every change automatically leads to a new submission. However, if the Intended Purpose, performance, technology, materials, or other safety- and efficacy-relevant characteristics change significantly, a new 510(k) may be required. This is precisely why it is important to assess changes in a structured manner and document them early, rather than deciding under time pressure at a late stage.

Since 2 February 2026, the FDA has been operating in the medical device area based on the new Quality Management System Regulation (QMSR). At the same time, the FDA has replaced the previous QSIT inspection model and now uses the updated Compliance Program 7382.850 for inspections. For manufacturers, this means that US-side process and inspection readiness must be considered early – not only shortly before a potential FDA Inspection.

Yes. Foreign manufacturers importing Medical Devices into the USA must designate a US Agent – a US-based person or organization that serves as a point of contact for the FDA. This agent must have sufficient regulatory knowledge of your product. We advise you on the selection and Regulatory Requirements for your US Agent.

Not automatically. Under QMSR, the FDA Inspection continues to follow FDA-specific requirements and does not simply follow the MDSAP audit plan; an ISO 13485 conformity certificate also does not exempt a company from an FDA Inspection. At the same time, the FDA can continue to accept MDSAP audit reports as a substitute for routine FDA Inspections. For manufacturers, it is therefore critical not to equate MDSAP, ISO 13485, and FDA inspection readiness, but to properly distinguish between them.

The Breakthrough Device Designation is a voluntary FDA program for certain products that may enable more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions. It is intended to accelerate development, evaluation, and review, and can be relevant for 510(k), De Novo, and Premarket Approval. Whether it is strategically sensible depends heavily on the product, clinical relevance, and overall strategy. ab.

The FDA is required to make a decision within 90 days of receiving all required documentation. In practice, however, a 510(k) procedure averages four to nine months – because the FDA pauses the process when it raises queries and only restarts it when answers are received. Currently, the FDA fees for submission amount to approximately USD 11,000 for standard companies and approximately USD 2,700 for small businesses. Additionally, there are costs for preparation, documentation, and consulting – the scope of which depends heavily on the product, the data situation, and the baseline status of the documentation. Experience shows that investing in submission readiness early saves more than it costs.

FDA clearance means that the FDA has determined your product to be substantially equivalent to an already approved product – it is not an approval in the sense of a comprehensive safety and efficacy review. Describing a 510(k) product as “FDA-approved” is technically incorrect and can lead to misleading labeling. Clearance authorizes marketing – but simultaneously obliges ongoing post-market obligations, reporting requirements, and inspection readiness. Furthermore, clearance is no guarantee of commercial success. Reimbursement, distribution structures, and market positioning must be addressed separately.