Food and Drug Administration's 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 FDA's approach to reviewing networked medical device cybersecurity during the premarket process.

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