FDA Law Blog
MARCH 7, 2024
Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development. The 2006 guidance noted that these would be “rare cases” limited to “specific issues of urgent concern.”
StorytellERdoc
JULY 10, 2014
When thinking about emergency room settings, even, one can easily correlate the words of Webster to what one would necessitate to be a situation requiring emergency medical treatment. When a critical illness or injury occurs, then, we should all be thankful that we live within a society where emergent, life-saving medical care is available.
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Today's Hospitalist
APRIL 24, 2025
Key takeaways: Admission delays from the ED can adversely affect mortality, length of stay, medical errors and quality of care. Those interventions included standardizing both bed assignments and nursing handoffs while having ED providers—not an inpatient team—enter skeletal orders when deciding to admit a patient.
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.
FDA Law Blog
NOVEMBER 1, 2023
Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.
FDA Law Blog
DECEMBER 12, 2022
In an appendix, FDA provides a model “decision check list” for patients. You should place your initials in the location provided next to each item to indicate that you have read and understood the item. It looks similar to the type of procedural informed consent a surgeon ordinarily would present to a patient.
Permanente Medicine
JUNE 3, 2025
Assistant Regional Medical Director, Care Experience Southern California Permanente Medical Group Podcast transcript Transcript is autogenerated. I practice family and sports medicine as part of the Southern California Permanente Medical Group here in Fontana, California. I joined SCPMG straight from residency in 2006.
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