USA: US Medical Device Classification Update: Intravascular Bleed Monitor & The Non-Implanted Electrical Stimulation Devices – July, 2022
- 2022-07-26 11:26:52
According to the De Novo Classification request from the respective manufacturers, the US FDA reviewed the request for the following devices, Intravascular Bleed Monitor and Non-Implanted Electrical Stimulation Devices for Management of Premature Ejaculation. As a result, both types of products are now classified as Class II products rather than belong to products of Class III.
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