FDA Cleared medical devices are ones that the FDA has determined to be substantially equivalent to another legally marketed device. A pre-market notification, referred to as a 510(k), must be submitted to the FDA for clearance. A 510(k) is most often submitted by the medical device manufacturer.
- "Clear" the device after reviewing a pre-market notification, otherwise known as a 510(k) (named for a section in the Food, Drug, and Cosmetic Act), that has been filed with FDA, or
- "Approved" the device after reviewing a pre-market approval (PMA) application that has been submitted to FDA.
Whether a 510(k) or a PMA application needs to be filed depends on the classification of the medical device.
To acquire FDA clearance to market a device using the 510(k) pathway, the submitter of the 510(k) must show that the medical device is "substantially equivalent" to a device that is already legally marketed for the same use.
To acquire approval of a device through a PMA application, the PMA applicant must provide reasonable assurance of the device’s safety and effectiveness.
Does clearance of TMS Therapy mean that all TMS devices are cleared for use in major depression within the United States?
NeuroStar TMS Therapy was the first TMS device to have been evaluated in a large, multi-center, controlled clinical trial, and was the first to be cleared by the U.S. FDA (in 2008) for the treatment of major depression. Since then, there have been many other TMS devices approved by the FDA.