The FDA has scheduled a meeting of its patient engagement advisory committee for Sept. 10, 2019 to discuss and make recommendations on medical device cybersecurity.
The committee’s recommendations will address which factors the FDA and medical device industry should consider when communicating cybersecurity risks to patients and to the public.
The FDA in recent years has increasingly paid attention to medtech’s cybersecurity challenges, publishing its first premarket cybersecurity guidance in 2014 and a postmarket guidance in 2016. In October 2018, the agency issued an updated draft premarket guidance that includes some postmarket information. It also held a public workshop in January to get feedback on that guidance and worked on Healthcare & Public Sector Health Coordinating Council’s joint security plan issued in January.
The FDA said it intends to make background material available to the public no later than two business days before the meeting, which is scheduled for 8 a.m. to 5:30 p.m. September 10 at the Holiday Inn Gaithersburg, Two Montgomery Village Ave., Gaithersburg, MD 20879. For more information, contact Letise Williams, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5441, Silver Spring, MD 20993-0002, letise.williams@fda.hhs.gov, 301-796-8398 or the FDA Advisory Committee Information Line, 1-800-741-8138.
