FDA News: AAMI Technical Information Report, Fraudulent Cancer Products
FDA BRIEF: Week of April 24, 2017
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
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