Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Implanted Electrical Stimulation Device for Management of Premature Ejaculation
fda-device · Food and Drug Administration · Rule · Published 2022-06-06 · Effective 2022-06-06 · 87 FR 34164
Document
Document number
2022-12082
Federal Register citation
87 FR 34164
CFR reference
21 CFR 876
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2022-06-06
Effective date
2022-06-06
HHS docket
Docket No. FDA-2022-N-0790
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the non-implanted electrical stimulation device for management of premature ejaculation into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the non- implanted electrical stimulation device for management of premature ejaculation's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.