Medical Devices

Public Workshop - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices January 29-30, 2019

The Food and Drug Administration (FDA) is announcing a public Workshop entitled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”. The purpose of the workshop is to discuss the newly released draft guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. FDA seeks to bring together diverse stakeholders to discuss, in-depth, the draft guidance, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” and the sub-topic of the draft guidance regarding a Cybersecurity Bill of Materials (CBOM), which can be a critical element in identifying assets, threats, and vulnerabilities.

The need for effective cybersecurity to assure medical device functionality and safety 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. In addition, cybersecurity threats to the healthcare sector have become more frequent, more severe, and more clinically impactful. Cybersecurity incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities in the US and globally. Such cyberattacks and exploits can delay diagnoses and/or treatment and may lead to patient harm.

Although FDA issued guidance addressing recommendations for device cybersecurity information in premarket submissions in 2014 , the rapidly evolving landscape, and the increased understanding of the threats and their potential mitigations necessitates an updated approach. This guidance is intended to provide recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk. These recommendations can facilitate an efficient premarket review process and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats.

Date, Time and Location:
This meeting will be held January 29th and January 30th 2019, beginning at 9:00 a.m. – 4:30 p.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

FDA Campus Information, (e.g., local airports, directions, local hotels, etc.)

The meeting will be webcasted.


Agenda is forthcoming

Registration to Attend the Workshop:

If you wish to attend this Workshop, you must register by 4:00 p.m. on January 22, 2019.

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.


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Contact Us

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661,

For questions regarding workshop content please contact:

Aftin Ross
Center for Devices and Radiological Health
Office of the Center Director
Emergency Preparedness/Operations & Medical Countermeasures
White Oak 66, Room 5402 | 10903 New Hampshire Avenue | Silver Spring, MD 20993
Office: 301-796-5679 Cell: (202) 870-0517

Page Last Updated: 01/17/2019
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