FDLI’s Top Food and Drug Cases, 2021 & Cases to Watch , 2022Judge Rotenberg Educational Center v. U.S. Food and Drug AdministrationJune 29, 2022 Download PDF
The U.S. Food and Drug Administration (FDA) had only exercised its authority to ban medical devices twice by the time it finalized its ban on electrical stimulation devices (ESDs) for patients with self-injurious behavior (SIB) and aggressive behavior (AB). Jeff Gibbs, Faraz Siddiqui and Veronique Li write about how this represented FDA’s first attempt to use this authority to ban a device for a particular use while allowing other uses, and the first time a device ban was challenged in court.
PDF Link attached is to full book. See page 15 for this chapter.
- Jeffrey N. Gibbs
- Veronique Li
Senior Medical Device Regulatory Expert
- Faraz R. Siddiqui