Cranial Stimulators Split By FDA Into Class III For Depression And Class II For Anxiety/Insomnia

In a Jan. 21 proposed order, FDA says it wants cranial electrotherapy stimulators to be split into two classifications: those intended to treat insomnia or anxiety into class II, special controls, and those intended to treat depression into class III, requiring a PMA.

FDA would reclassify cranial electrotherapy stimulators (CES) into two separate classes, placing those intended to treat insomnia and anxiety into class II, with special controls to mitigate risks, and those designed to treat depression into class III requiring a PMA, under a proposed order

released Jan. 21.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

More from Policy & Regulation

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By 

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.

With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?

US FDA Unveils Plans To Consolidate Support Services

 

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.