FDA Reclassification
In 2019, the FDA finalized a reclassification of CES devices:
- Devices for treating insomnia and anxiety moved to Class II (lower risk) with special controls
- Devices targeting depression maintained as Class III (high risk) with a more involved Premarket Approval (PMA) pathway
Challenges for Startups
- Long approval processes (PMA can take years)
- Need to demonstrate both safety and efficacy
- Different requirements for different markets