Public Workshop

The Food and Drug Administration (FDA) is announcing a public workshop entitled “The Role of Hospitals in Modernizing Evidence Generation for Device Evaluation: Harnessing the Digital Revolution for Surveillance.” Hospitals play a critical role in the development of these national capabilities, leading to more robust evidence generation. Recently, the role of hospital reporting of device-related adverse events in device surveillance and, more generally, device evaluation, has garnered increased scrutiny. This public workshop will further explore the critical role of hospitals in the evolution of device surveillance and in creating more robust surveillance capabilities.


Date, Time and Location

This meeting will be held December 5, 2016, beginning at 8:30 a.m. to 5:00 p.m. ET, at the following location:

Fishers Lane Conference Center Terrace Level
5635 Fishers Lane
Rockville, MD, 20852

The workshop will be webcast and the webcast link will be available on this web page by November 29, 2016.

Registration to Attend the Workshop

If you wish to attend this Workshop, you must register by 4:00 p.m. on November 28, 2016. 

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. 

If you wish to make an oral presentation during any of the open comment sessions at the meeting you must indicate this at the time of registration. FDA requests that presentations focus on the areas defined in the Federal Register Notice. You should also identify which discussion topic you wish to address in your presentation and you must submit a brief statement that describes your experience and/or expertise relevant to your proposed presentation. In order to keep each open session focused on the discussion topic at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak.

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. 66, Silver Spring, MD 20993, 301-796-5661, [email protected].

For questions regarding workshop content please contact:

Jill Marion, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 3110, Silver Spring, MD  20993, 301-796-6128, [email protected]