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JD Supra: Every Little One, Every Little One: FDA Issues a Warning Letter to a Medical Device...
JD Supra· 22 hours agoThis Bulletin summarizes the issues involved and our observations. FDA inspected the company and issued a Form FDA 483 List of Inspectional Observations ...
FDA Disregards Deadline To Ban Cancerous Formaldehyde Found In Hair Relaxers
Black Enterprise· 22 hours agoThe Food and Drug Administration missed its own deadline to ban formaldehyde in hair-straightening products. The FDA hasn’t released a statement on why the ban has yet to ...
Apple Watch series AFib monitor getting FDA medical certification
Android Headlines· 19 hours agoThe Apple Watch series AFib feature has received new approval from the FDA. From now on, the results...
FDA approves over-the-counter sales of Narcan. But would you know what to do to save a life?
WPXI· 1 day agoMost of the drug overdoses are caused by opioids or fentanyl. In a move that health experts say may...
United Imaging secures FDA clearance for uMR Jupiter 5T MRI system
Medical Device Network via Yahoo Finance· 1 day agoUnited Imaging, a medical imaging and radiotherapy equipment maker, has secured the US Food and Drug...
FDA issues final rule regulating LDTs as medical devices
Medical Device Network via Yahoo Finance· 3 days agoThe FDA ruling follows years of industry back and forth and sees the government body choosing to...
FDA Finally Moves to Scrutinize Specialized Health Screenings
ProPublica· 2 days ago“This is a significant step forward,” said Peter Lurie, president and executive director of the...
FDA brings lab tests under federal oversight in bid to improve accuracy and safety
ABC News· 4 days agoThe goal is to ensure that new tests for cancer, heart disease, COVID-19, genetic conditions and...
FDA Issues Much-Anticipated Final Rule on Laboratory Developed Tests | JD Supra
JD Supra· 1 day agoThe final rule amends FDA regulations to make it explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD ...
FDA brings lab tests under federal oversight in bid to improve accuracy and safety
NBC NEWS· 4 days agoThe goal is to ensure that new tests for cancer, heart disease, Covid, genetic conditions and many...