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Food and Drug Administrationís Review of Networked Medical Device Cybersecurity During the Premarket Process

FDA reviews different types of medical devices, such as those that are wireless, Internet, and network-connected (networked medical devices), before they are legally marketed in the United States to assess whether they are safe and effective for their intended use. Networked medical devices, however, are vulnerable to cybersecurity threats that may adversely affect device functionality, disrupt delivery of health care, and/or cause patient harm. We will interview FDA staff and review a purposive sample of premarket files to examine FDAís approach to reviewing networked medical device cybersecurity during the premarket process.

Announced or Revised Agency Title Component Report Number(s) Expected Issue Date (FY)
Nov-16 Food and Drug Administration Food and Drug Administrationís Review of Networked Medical Device Cybersecurity During the Premarket Process Office of Evaluation and Inspections OEI-09-16-00220 2018

Office of Inspector General, U.S. Department of Health and Human Services | 330 Independence Avenue, SW, Washington, DC 20201