Cosmetics Marketing Radiology Regulation 
FDA Law Blog
JUNE 28, 2023
Baumhardt, Senior Medical Device Regulation Expert & Philip Won — The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions.
The Pharma Data
NOVEMBER 6, 2020
Food and Drug Administration (FDA) permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). . SILVER SPRING, Md. , .
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The Pharma Data
APRIL 20, 2022
director of the FDA’s Center for Devices and Radiological Health. All NIPS tests on the market today are offered as laboratory developed tests (LDTs). Without proper understanding of how these tests should be used, people may make inappropriate health care decisions regarding their pregnancy. Source link: [link].
FDA Law Blog
OCTOBER 14, 2021
Mullen — In recent years, for novel robot assisted surgery (RAS) devices, FDA’s Center for Devices and Radiological Health (CDRH) has taken the approach of clearing RAS devices for specific indications for use. Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes.
The Pharma Data
NOVEMBER 12, 2021
director of the FDA’s Center for Devices and Radiological Health. “We An FDA investigator’s list of examination compliances doesn’t constitute a final FDA determination of whether any condition is in violation of the Federal Food, Drug, and Cosmetic Act or any of its enforcing regulations. Source link: [link].
pharmaphorum
OCTOBER 4, 2022
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.
The Pharma Data
FEBRUARY 23, 2022
Food and Drug Administration authorized the marketing of the first condoms specifically indicated to help reduce transmission of sexually transmitted infections (STIs) during anal intercourse. director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health.
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