A medical device that is similar to another medical device being legally marketed must be cleared through a regulatory process called premarket notification. Section 501(k) of the FD&C Act prescribed premarket notification; therefore, the process is commonly called the 510(k) process. FDA may issue an order of substantial equivalence only upon making a determination that the device to be introduced into commercial distribution is as safe and effective as a legally marketed device. This legally marketed device is called the predicate device for the device that is seeking clearance.
PMA is an application for the approval to allow high-risk devices to be put into commercial distribution. PMA allows a device maker to demonstrate to FDA that the device is reasonably safe and effective on its own. Before a novel medical device can be legally put into commercial distribution, by law it is required to demonstrate its safety and effectiveness.
A 510(k) submission that leads to a determination of “not substantially equivalent” may be followed by a petition for de novo classification. This is a process for medical devices that are low to moderate risk but have been classified in Class III, because FDA has found them to be not substantially equivalent (NSE) to legally marketed predicate devices.
A request to FDA to make a risk based classification of the device into Class I or Class II can be initiated when there is no legally marketed device upon which to base a determination of substantial equivalence without first submitting a 510(k) and receiving a not substantially equivalent (NSE) determination.
HDE provides a regulatory path for Class III devices that are intended to benefit patients with rare diseases or conditions. In order for a device to be eligible for an HDE, a sponsor must obtain designation as a Humanitarian Use Device (HUD), which is granted through application to FDA’s Office of Orphan Products Development (OOPD).
For information on how to request Humanitarian Use Designation, see Designating Humanitarian Use Device (HUD).