Responding to concerns about ‘over criminalization’ of companies subject to deferred prosecution agreements, FDA and DOJ attorneys note that getting a form 483 won’t breach compliance provisions. Avanos Medical’s 2021 agreement is to be model going forward.

Responding to concerns about ‘over criminalization’ of companies subject to deferred prosecution agreements, FDA and DOJ attorneys note that getting a form 483 won’t breach compliance provisions. Avanos Medical’s 2021 agreement is to be model going forward.

The settlements resolve False Claims Act allegations against St. Jude and Alere, as well as misbranding allegations against Avanos Medical.

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.