While oncology is our core expertise, Medelis also has deep experience designing and managing studies for medical devices, including those used in surgical and dental applications.
Our experts can evaluate your device and assist in determining whether a clinical study is necessary by determining:
- The risk class that the device falls into
- If the device is substantially equivalent to a device already on the market
Risk Categories in the United States
In the United States, the FDA has published its categorization of medical devices. Risk categories are similar in other countries, although some differences do exist.
The FDA Center for Devices and Radiological Health is responsible for medical device market clearance or approval. Most Class 2 medical devices require the submission of a 510(k) premarket notification to FDA. Most of the information submitted in a 510(k) premarket notification is of a nonclinical nature, and currently only 10% to 15% of 510(k) submissions are submitted with clinical data to demonstrate substantial equivalence.
High-risk medical devices or Class 3 and Class 2 medical devices that are not substantially equivalent to another approved product require premarket approval (PMA) prior to marketing. All PMA submissions contain clinical data, but the volume of data included is generally much smaller than that included in a similar application for a new drug. A recent review of the summaries of safety and effectiveness data for 78 PMAs for high-risk cardiovascular devices showed that 65% of the FDA approvals were based on a single study that included an average of 300 patients.
Risk Categories in Europe
As of 2010, all medical devices marketed in the EU (regardless of classification) must have a clinical evaluation on file with the regulatory authorities. Without this clinical evaluation, which may include information from clinical studies, the device may not be marketed or sold.
Although the regulatory approval process is quite different in the EU, the same high-level principle applies: Before a device can be marketed, the developers must demonstrate the new product is safe and effective. As in the United States, the type and amount of data required for review varies by type of device as well as risk; however, every medical device sold in the EU (regardless of classification) must have a clinical evaluation report in its technical file.
If you’d like to talk to us about your medical device, contact us.