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FDA Tag

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US regulators have published updated draft guidance on recommendations for distribution of scientific and marketing materials related to unapproved uses of medical devices, drugs and other products under Food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...

Is a 510 (k) a Race? Sort Of.

Well, I guess it’s safe to come clean now.  I cheated on my French test in high school by conjugating the verbs on suede shorts I bought with the intention to cheat.  Right before the test I wrote the verb tenses with my finger on...