Tag Archives: Food and Drug Administration (FDA)

Hidden FDA Reports Detail Harm Caused by Medical Devices

The FDA keeps suppressed lists of medical device failures.  You can read about it on Medscape: FDA spokeswoman Deborah Kotz confirmed that the “registry exemption” was created without any public notice or regulations. “Any device manufacturer can request an exemption … Continue reading

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Unnecessary regulation impedes clinical innovation

Will Regulatory and Financial Considerations Dampen Innovation in the Clinical Microbiology Laboratory? Peter H. Gilligan,  Melissa B. Millera Address correspondence to Peter H. Gilligan, gilliganncphd@gmail.com. ABSTRACT Over a million prosthetic joints are placed in patients in the United States annually. Of … Continue reading

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Not actually tested – The 510(k) Ancestry of a Metal-on-Metal Hip Implant

In recent years, metal on metal hip replacements have been causing problems, depositing worn-off metal around the body and having to be taken out. A NEJM paper shows the ancestral tree of hip replacements. The authors describe how new devices’ safety … Continue reading

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Bureaucracy killing research

While research and the USA largely get by just fine without ISO lab standards and this paper therefore does not mention them, it does illustrate the effects of analogous bureaucracy in the marked decline of clinical research.  Food and Drug … Continue reading

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