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Considerations for Mobile Health Technology Developers: Part 2

pharmaphorum

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criteria for regulation.

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FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults

The Pharma Data

director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. This device was studied in a 30-day randomized, sham-controlled trial of 70 patients. Patients in the sham group wore the device, but no vibratory stimulation was provided.

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FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse

The Pharma Data

director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health. The safety and efficacy of the One Male Condom was studied in a clinical trial comprised of 252 men who have sex with men and 252 men who have sex with women. Source link: [link].