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.
FDA Law Blog
AUGUST 18, 2024
Gibbs — In 1997, Congress wisely amended the Federal Food, Drug, and Cosmetic Act (FDCA) by adding Section 513(f)(2) to establish the De Novo process. By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N.
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The Pharma Data
APRIL 15, 2022
director of the FDA’s Center for Devices and Radiological Health. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. for the next public health emergency.”. Source link: [link].
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.
The Pharma Data
APRIL 20, 2022
director of the FDA’s Center for Devices and Radiological Health. While LDTs are medical devices under the Federal Food, Drug, and Cosmetic Act, the FDA has had a general policy of enforcement discretion for most LDTs since the Medical Device Amendments were enacted in 1976. Source link: [link].
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
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].
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