Medical device manufacturers and health care providers should be aware of, and may want to participate in, an important ongoing matter at the Federal Communications Commission (“FCC”). The FCC is considering initiating a rulemaking (and is seeking comments as to whether it should do so) that will impact

• How medical implant and body-worn devices will be manufactured and designed in the future, and the restrictions and limitations on such manufacture and design;
• The costs of designing and manufacturing such devices (which also impacts the price that will be charged to health care providers for such devices); and
• The extent to which such devices may be subject to harmful interference from other sources that prevents them from operating properly.

Specifically, the FCC is seeking input from medical device manufacturers, hospitals, assisted living facilities and other interested parties in a regulatory matter that will have significant implications with regard to (i) implanted, body-worn and associated external medical devices, and (ii) their uses in hospitals, assisted living facilities, physicians’ offices and patients’ homes.

Recently, the FCC released an order granting one manufacturer, Dexcom, Inc., a waiver to manufacture certain equipment (blood glucose monitoring equipment) that would otherwise violate FCC rules, but such waiver is for a limited duration (the greater of (i) three years, or (ii) one year from the date in which the FCC adopts new rules regarding medical implant devices). The FCC’s decision to limit the duration of the waiver indicates that it wants to fully and finally decide the issues involved in the context of a global proceeding.

Such a proceeding will greatly impact

• Manufacturers of medical devices, such as cardiac pacemakers, that communicate time sensitive data.
• Manufacturers of implanted devices and other external sensors that communicate non-time-sensitive data, such as oxygen levels, glucose levels and blood pressure.
• Hospitals, assisted living facilities and physicians.

If you wish to receive additional information about this matter, or if you may wish to participate in this matter, please contact:

Alan Fishel
(202) 857-6450
fishel.alan@arentfox.com

Jeffrey Rummel
(202) 715-8479
rummel.jeffrey@arentfox.com