FDA Issues Challenge To Medtech To Fight 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.
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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.
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.
Industry groups praised newly enacted opioid-control legislation Oct. 24. The legislation will put more attention on existing medtech alternatives to addictive opioids and support research on new devices. Industry was positive about the new law, despite its expansion of sunshine reporting requirements that they oppose.