Rapid Release Gets Warning Letter for PMA
Rapid Release Technologies received a warning letter for failing to apply for premarket approval (PMA) or an investigational device exemption (IDE) for a massage device.
The company’s Rapid Release Massager was classified under regulations pertaining to therapeutic vibrators and powered heating pads, both of which are generally exempt from premarket notification.
During an inspection of Rapid Release’s Santa Ana, Calif., facility in May 2016, the FDA discovered evidence that the company’s device was actually marketed for uses different from those of these generic device types. — Jeff Kinney