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


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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