January 26, 2012 - Bloomberg BNA and Fish & Richardson present “The Future of Wireless Medical Devices” on January 26, 2012 from 1:00 – 2:30 pm ET. For more information click here.

October 25, 2011 - Fish & Richardson and CBI present “The Future of Wireless Medical Devices - FCC, FDA, and Patent Considerations.”  Speakers include Keith Barritt (DC), Terry Mahn (DC), William Hunter (Southern California) and Charles Gropper from CardioNet.

Watch the presentation here.

July 26-27, 2010 - The Federal Communications Commission and Food and Drug Administration held a joint public hearing on wireless medical devices in Washington, D.C. The purpose of the hearing was to gather information on the developing market for wireless medical devices and explore how the two agencies might cooperate in the future to help streamline the marketing authorization process. Specific topics of discussion included: (1) data integrity and reliability issues; (2) device and system security issues; (3) trends in medical devices using allocated spectrum and spectrum that does not require an FCC license; (4) risk management; and (5) current FDA and FCC regulatory requirements.  Additional information can be found here.

At the public hearing, the FCC and FDA released a joint Memorandum of Understanding in which both agencies agreed to work together to promote initiatives related to the review and use of FDA-regulated medical devices that utilize radiofrequency emissions. Click here to view. 

The MOU is intended to promote collaboration and ultimately improve the efficiency of the regulatory processes for such devices. The goals of the MOU are to explore ways to: (1) enhance information sharing to ensure the safety and efficacy of medical devices; (2) improve the efficiency of both agencies’ regulatory schemes; (3) promote efficient utilization of “tools” and expertise for product analysis, validation, and risk identification; and (4) build “infrastructure and processes” that meet the agencies’ common needs.

• Wireless Medical Technologies – Fish & Richardson White Paper
  
• Wireless Medical Devices: Navigating Government Regulation in the New Digital Age

• July 21, 2011, FDA Draft Guidance - Mobile Medical Applications
  
• Guidance for Industry - Wireless Medical Telemetry Risks and Recommendations
  
• FDA overview of medical device regulation
  
• FDA January 2007 draft guidance on "Radio Frequency Wireless Technology in Medical Devices"
  
• FDA January 2002 guidance on "General Principles of Software Validation"

• Wireless Medical Telemetry Service
  
• Medical Device Radiocommunications Service
  
• MedRadio Operations Rules