The Food and Drug Administration (FDA) regulates prescription drugs and medical devices under the Federal Food, Drug and Cosmetic Act (FDAC)[1] and FDA’s implementing regulations.[2] This section contains documents describing FDA’s interpretation of its FDCA mandate with respect to the practice of telemedicine.

FDA defines telemedicine as the “application of telecommunications to the care of individual patients.”[3] Telehealth includes the transmission of patient information, remote consultation and follow-up services, home health monitoring, professional and patient education, and even telerobotic surgery. It improves access to health care services for patients located in isolated communities, and it enhances the ability of health professionals to treat patients effectively and efficiently.

When equipment or software is intended for use in the diagnosis or treatment of a disease or other condition, FDA considers the equipment or software to be a medical device.[4] FDA requires registration and listing, premarket notification and/or approval, good manufacturing practices (GMPs), and postmarket surveillance. Further information on FDA’s regulation of medical devices as it pertains to telemedicine can be found here.

FDA also regulates the software used in telehealth systems. This section includes FDA’s guidance on medical imaging software, highlighting the distinction between products that are not specifically intended for medical use and those devices specifically related to the storage, processing and display of medical images. This section also includes the January 2002 final guidance document on the General Principles of Software Validation.

E-Health is the area of telehealth that involves the exchange of health-related information, products, and services over the Internet. The recent proliferation of e-health businesses has drawn FDA’s attention to the promotion and sale of prescription drugs, medical products, and health-related services via the Internet. FDA is undertaking a variety of endeavors aimed at educating consumers of the need to exercise caution in researching and buying prescription medication and medical devices online. This section provides advice for consumers who purchase health care products over the Internet.

This section provides examples of FDA’s telemedicine-related enforcement actions, including warning letters and indictments. As the Federal Trade Commission (FTC), state enforcement agencies, and industry coalitions join FDA in the monitoring of telemedicine activities, the frequency and number of enforcement actions are expected to continue increasing rapidly.

[1] 21 U.S.C. § 301 et seq., amended by The FDA Modernization Act of 1997, Pub. L. 105-115, 111 Stat. 2296 (1997). [2]21 U.S.C. § 1 et seq. (1997). [3]FDA Center for Device and Radiological Health (CDRH), White Paper on Telemedicine Related Activities (1996). [4]The Federal Food, Drug and Cosmetic Act defines “device” as instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or function of the body of man or other animals, and which does not achieve its primary intended purpose through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. 21 U.S.C. § 321(h) (2000).