FDA BRIEF: Week of April 24, 2017

Logo of AAMI: Advancing Safety in Healthcare Technology

AAMI Technical Information Report on “Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems.”

FDA + Association for the Advancement of Medical Instrumentation (AAMI) report

  • Applies to medical devices and medical electrical equipmen) that incorporate Radio Frequency (RF) wireless technology
  • Used to perform or control a medical function or to communicate medical data
  • Directly support the medical device’s intended use
  • In alignment with FDA Guidance on RF wireless technology

Provides consensus process for risk management of coexistence of wireless medical devices and systems with other wireless products

  • Includes implanted cardiac pacemakers and cardioverter defibrillators, numerous physiological monitoring devices, implantable neurostimulators, drug and insulin infusion devices, diagnostic imaging systems, and a wide range of other medical devices

READ


image of fake cancer cures

FDA Takes Action Against Fraudulent Cancer Products

14 companies peddling bogus cancer cures have received warning letters from FDA

  • Untested and potentially dangerous products,  selling on the internet
  • Fraudulent products attempt to subvert compliance and enforcement efforts by changing the names of their products, their companies, and/or their websites

Fraudulent claims, Red Flags

  • Treats all forms of cancer
  • Miraculously kills cancer cells and tumors
  • Shrinks malignant tumors
  • Selectively kills cancer cells
  • More effective than chemotherapy
  • Attacks cancer cells, leaving healthy cells intact
  • Cures cancer

FDA response

  • Compliance and enforcement actions against unscrupulous companies
  • Consumer education to decrease demand

 

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