FDA committee to hold public meeting on cybersecurity in medical devices

July 9, 2019

The Food and Drug Administration (FDA) has announced a public advisory committee meeting of the Patient Engagement Advisory Committee (the Committee) will be held September 10 in Maryland to provide advice to the Commissioner, or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients.

Medical devices are increasingly connected to the internet, hospital networks, and other medical devices to provide features that improve healthcare and increase the ability of healthcare providers to treat patients, FDA said, noting that the same features may also increase cybersecurity risks. Preserving the benefit of these devices requires continuous vigilance as well as timely and effective communication to medical device users about evolving cybersecurity risks.

The recommendations provided by the committee will address which factors should be considered by FDA and industry when communicating cybersecurity risks to patients and to the public, including but not limited to the content, phrasing, the methods used to disseminate the message and the timing of that communication. The recommendations will also address concerns patients have about changes to their devices to reduce cybersecurity risks as well as the role of other stakeholders such as healthcare providers in communicating cybersecurity risks to patients.

Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee. Oral presentations from the public will be scheduled between approximately 10:45 a.m. to 12:15 p.m. on September 10, 2019. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before July 22, 2019.

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting.

The meeting will be open to the public on September 10, 2019, from 8 a.m. to 5:30 p.m. at the Holiday Inn Gaithersburg, Two Montgomery Village Ave., Gaithersburg, MD.