i-FDA: The Process
FDA Medical Device: Definition, Approval Process, Regulations, Recalls, Database, Reporting, and Recalls
See this video below, of the CIMIT Accelerator Program, for Medical Devices on the sometimes long, tortuous road to FDA approval
FDA Device Approval Process
All new drugs, and medical gadgets, or devices must get FDA approval before being legally used to treat patients. (see the FDA website for particulars). The drug approval process is much more rigorous and lengthy, lasting almost a decade.
Basically, there are stages that the proposed medical device must go through:
1) For a device, a 510(k) is simply a submission to the FDA of a device to show it is safe and useful, and must be made to the FDA 90 days before going on the market. To see what devices are in the 510 database, go HERE. This process is considered to be a “fast-track” loophole for medical devices, since it the proposed devices only needs to show it is similar to an existing product, and some congressmen, as of August 2012, are trying to amend this process that bypasses the normal approval process, since some devices are actually similar to recalled devices.
2) PMA, or pre-marketing submission is stricter, and is a determination of the FDA that the device is safe and medically useful. To see the database of devices in the PMA stage, go HERE.