The New York Times last Friday released an editorial calling for improved regulation on medical devices from the FDA, citing a number of recent controversial devices that have made headlines for injuries and deaths related to their use. If you want to read more about this news click here.
Since December 1st, 2018 a historical change in administration that consisted of a new president who is committed to Public Office cleansing of corrupt and unequal practices had a strong impact on the whole country course of operation. Many institutions were eliminated or were audited and restructured. Cofepris was audited and analyzed for permanence or …
«The Food and Drug Administration (FDA, Agency) identified a list of class I devices and class II devices that are now exempt from premarket notification requirements, subject to certain limitations. FDA published the lists of final determinations in accordance with procedures established by the 21stCentury Cures Act (Cures Act). Although each classification regulation for each …
Researchers who monitored people with deep brain stimulation implants for 8 years suggest that the treatment can benefit those with severe depression. Regulators in the United States have already approved deep brain stimulation for the treatment of Parkinson’s disease, epilepsy, essential tremor, and obsessive-compulsive disorder. The treatment involves implanting wires into the brain and a stimulator in the chest …
