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Johnson & Johnson’s (JNJ) DePuy Synthes Class I Recall

August 28, 2014 #JNJ #Recall #DePuy Synthes Johnson & Johnson DePuy Synthes Class I Recall 3D Printing (like on the image above)  has been used for years in surgery when making Medical Models that cast an image of a patient's head to help in pre-surgery planning of difficult cases; and, one...

Doctors Crying Over “Sunshine”? The Sociopathic Business Model™Edition

July 29, 2014 More Sunshine! As previously discussed the Sunshine Act reports physician's financial interactions with  manufacturers of drugs and medical devices to the CMS.   That information is about to be released to the public but some doctors are not happy about the transparency. According to WSJ Pharmalot: A group...

MAUDE: What Any Surgical Patient Needs to Read

MAUDE Manufacturer and User Facility Device Experience Database What every patient should know prior to going into surgery and if there are problems reported during your surgery. MAUDE data mandatory from the FDA represents reports of adverse events involving medical devices. The data consists of voluntary reports since...

The FDA and The Socipathic Business Model™ Case Study

The essence of good government is trust. Kathleen Sebelius From JAMA:  The Food and Drug Administration (FDA) acted without regard for employees’ whistleblower rights, according to a joint staff report released February 26 by Rep Darrell Issa (R, Calif), chairman of the House Committee on Oversight...

The FDA Wants You!

US regulators have published updated draft guidance on recommendations for distribution of scientific and marketing materials related to unapproved uses of medical devices, drugs and other products under Food and Drug Administration oversight. The agency is accepting public comments on the guidance through April 2014. Device manufacturers intending...