Gottlieb Points To Breakthrough And Localized Therapy Devices For Non-Opioid Pain Control
In one of his last public appearances as US FDA commissioner, Scott Gottlieb identified new opioid-alternative medtech products in the regulatory pipeline that provide distraction therapy and thermal management for pain relief. The agency chief also pointed to old-school devices that provide localized delivery of analgesic drugs as effective opioid-substitute or opioid-reducing devices.
You may also be interested in...
The commissioner says he will step down next month, leaving a legacy of active policy development, but also a lot of initiatives and pilot projects that are in the middle of being implemented.
After spending the past six months receiving and reviewing hundreds of product applications, US FDA has decided to select eight promising devices and diagnostics to help tackle the opioid crisis.
Echoing President Trump's ongoing call to fight the opioid-abuse epidemic, the US agency is asking medtech companies to submit applications for new products to tackle the issue. Promising devices and diagnostic tools identified by the agency will get extra attention from FDA, but they won't have to submit an additional application for a Breakthrough Device designation.