The Food and Drug Administration (FDA) is holding a meeting July 26-27 on the topic of converged communications and medical devices. The meeting is to collect information and comments from stakeholders about how the FDA can simplify and coordinate regulatory approval. The meeting is in conjunction with the Federal Communications Commission (FCC). The agencies hope to enhance coordination on convergent medical device and information technology.

The FCC regulates equipment like smart phones, personal digital assistants, wireless routers, and video-conferencing equipment that medical professionals use in managing patient care. The FDA regulates medical devices that may also use communication technology. Some devices are regulated by both agencies. The rising development and use of communication technology in medical devices has led to concerns including manufacturers' difficulty in complying with regulatory requirements and issues in medical device system spectrums.

The FDC and FCC meeting will focus upon developing the definition and scope of topics, as well as recommendations on the following:

-- Data integrity and reliability issues with allocated spectrum, unlicensed devices, use of commercial networks and applications, and 'medical-grade' wireless technology and communications;

--Medical device and system security issues such as inadvertent and intentional intrusion, non-function and malfunction;

--Trends in medical devices using allocated spectrum and using unlicensed operation, and medical devices and applications using commercial networks;

--Risks Management, such as defining levels of "criticality" of device function for determining reliability requirements, and environmental factors and delivery setting;

--Views on current FDA and FCC regulatory requirements.

The meeting will be held in the FCC Commission Meeting Room, 445 12th St., SW Washington, D.C., 20554. Registration requests must be received by 5 p.m. on July 19, 2010. Interested persons may register by e-mailing FCC-FDAMeeting(at)fcc.gov. Registrants must provide their names, titles, company or organization, mailing address, telephone number, and e-mail address. More information on the meeting will be available through www.regulations.gov, referencing FDA-2010-N-0291. Comments can also be submitted through that site.

More on the FDA meeting can be found at: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm215046.htm

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