US Market for Medical Technology – What Manufacturers Need to Consider for Market Access
Access to the US medical technology market is considered lucrative – however, it is highly regulated and costly. The US regulatory agency FDA differentiates between several procedures that vary depending on the risk class of the product.
Overview of Approval Procedures:
- For products with low to moderate risk (Class I and II), a 510(k) application is often sufficient. This demonstrates comparability to an already approved product.
- High-risk products (Class III), such as mechanical heart valves, require a Premarket Approval (PMA), which demands extensive clinical data.
Streamlined Approval Pathways:
Innovative manufacturers – particularly SMEs – benefit from programs such as:
- Breakthrough Devices Program: expedited approval for particularly innovative solutions (2024: 166 approvals).
- De Novo Procedure: for novel products without a comparator device, with moderate risk.
- Humanitarian Device Exemption (HDE): applicable for rare diseases (under 8,000 patients annually).
- Safer Technologies Program (STeP): for technologies that make existing treatments safer.
Regulatory Particularities:
Foreign manufacturers must register with the FDA for a fee and appoint a local agent. Additionally, complex regulations regarding product labeling apply.
Our Tip:
Manufacturers looking to export to the US should have their approval strategy legally reviewed early on. Incorrect classifications or incomplete applications can be costly.
Source: https://www.gtai.de/de/trade/usa-wirtschaft/medizintechnik