FDA Issues Guidelines On Wireless Medical Devices

The Food and Drug Administration (FDA) has released final guidelines on the design, testing and use of radio-frequency (RF) wireless medical devices. Although it doesn't promulgate legally enforceable responsibilities, the document is intended to guide both device manufacturers and healthcare providers toward the safe and secure use of wireless medical devices. Covered are devices "that are implanted, worn on the body or other external wireless medical devices intended for use in hospitals, homes, clinics, clinical laboratories, and blood establishments."

The FDA document has no relation to the impending guidance from the agency about how it will regulate apps that turn smartphones and tablets into medical devices. In fact, the draft guidance on RF wireless devices was issued in 2007, before smartphones and tablets became a factor in the industry. The FDA is focusing on the safety aspects of medical devices in hospitals, homes and other fixed-care settings.

For example, the guidance states, "Because there are risks associated with RF wireless systems, we recommend that you carefully consider which device functions should be made wireless and which device functions should employ wired connectivity."

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