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FDA Provides Update on Recall of Certain Philips Respironics Breathing Assistance Machines

The Pharma Data

director of the FDA’s Center for Devices and Radiological Health. “We During the examination, the FDA investigator made several compliances that are outlined in an examination bonus report, also known as an “ FDA Form 483.” The FDA investigator handed a list of their compliances to the company. Source link: [link].

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FDA Phones a Friend: Joint Statement with CMS Eschews CLIA Modernization and Supports FDA Oversight of LDTs

FDA Law Blog

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). Javitt & Allyson B.

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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.