Recognizing that the need for effective cybersecurity to ensure medical device functionality has become more important with the increasing use of wireless, Internet- and network-connected devices, and the frequent electronic exchange of medical device-related health information, the FDA has issued a draft guidance providing recommendations to consider and document in medical device premarket submissions.

The FDA defines cybersecurity as “the process of preventing unauthorized modification, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient.”

The recommendations contained in this guidance document are intended to supplement FDA’s “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” and “Guidance to Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software.” This guidance document is open for comments for a period of 90 days.

Source 

Topics:
FDA Compliance/Regulatory Affairs Government Implants & Prosthetics Medical Patient Monitoring RFID and UDI Tracking Regulatory and Guidance Documents

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