April 2022 Premarket Notification 510(K) Clearances: 256 Medical Devices
March 2022 Premarket Notification 510(K) Clearances: 288 Medical Devices
There are no FDA-approved drugs containing delta-8 tetrahydrocannabinol (delta-8 THC). Any delta-8 THC product claiming to diagnose, cure, mitigate, treat, or prevent diseases is considered an unapproved new drug. The FDA has not evaluated whether these unapproved drug products are effective for the uses manufacturers claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products, or whether they have dangerous side effects or other safety concerns.
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