The Pharma Data
APRIL 15, 2022
Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection. director of the FDA’s Center for Devices and Radiological Health. Today, the U.S. for the next public health emergency.”.
The Pharma Data
APRIL 20, 2022
Food and Drug Administration is warning the public of the risk of false results, inappropriate use and inappropriate interpretation of results with non-invasive prenatal screening (NIPS) tests, also called cell-free DNA tests or non-invasive prenatal tests (NIPT). director of the FDA’s Center for Devices and Radiological Health.
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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 12, 2021
Food and Drug Administration is providing an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. director of the FDA’s Center for Devices and Radiological Health. Today, the U.S. 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. By Jeffrey K. Shapiro & Allyson B. Gone are the days of tool type indications for this type of device. 21 U.S.C. §
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). Food and Drug Administration. .
FDA Law Blog
FEBRUARY 4, 2024
Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs). By Steven J. Gonzalez & Gail H.
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