Previously we’ve discussed FDA Class I medical devices, which are the lowest levels of risks. But what about medical devices that are the riskiest or have the most unknown risk? The FDA regulates medical devices based on the risk-benefit profile. Medical devices with a higher risk profile or lower perceived benefits are classified as Class III medical devices.
Class III medical devices can be any type of device, including diagnostics. Class III devices commonly include products with incredibly innovative technologies, long-term implantables, and breakthrough medical devices. The FDA defines a class III device as a device with one or more of the following:
- Used in sustaining or supporting life
- Has considerable significance in preventing the impairment of human health
- Presents a possibility of unreasonable risk of injury or illness
FDA maintains a higher level of control over class III medical devices. Class III medical device manufacturers must provide a substantial amount of data to the FDA prior to receiving FDA approval and provide continuous post-market data to the FDA to support the marketing of their device. Manufacturers of class III medical devices are typically subject to a “Premarket Approval Application” or PMA submission to FDA.
Premarket Approval Applications
PMA submissions are a lengthy application process with the FDA. Manufacturers developing class III medical devices will need to have discussions with the FDA before submitting their application. Most PMA submissions will require some level of human clinical data through a clinical trial. Prior to submitting a PMA, manufacturers will likely need to submit an investigational device exemption (IDE) to collect human clinical data.
Unlike the 510(k) application process, PMA submissions do not rely on the use of a predicate device. So all bench, pre-clinical, and clinical testing must support the safe and effective use of the product, rather than substantial equivalence. Class III devices and PMA submissions require expertise from many different disciplines because of the amount of evidence needed to support the device’s use.
FDA Approval of Class III Medical Devices
After receiving FDA approval for a Class III device, manufacturers are still subject to different requirements. In the approval letter, FDA may specify specific post-market requirements such as registry efforts, annual data submissions, or post-market clinical trials. Manufacturers will have to periodically submit reports to FDA about their class III devices. These reports are typically yearly reports called “annual reports” and include information like annual sales data, trending complaints, metrics on patients or usage, and a literature search. However, FDA may request annual reports quarterly or biannually.
If your organization is evaluating or developing a class III device, DeviceLab can help help you with design, prototyping, manufacturing, regulatory, and marketing to bring your product to patients and providers. Contact DeviceLab to schedule a consultation.