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  5. Virtual Public Workshop – Transparency of Artificial Intelligence/Machine Learning-enabled Medical Devices - 10/14/2021 - 10/14/2021
  1. Workshops & Conferences (Medical Devices)


Event Title
Virtual Public Workshop – Transparency of Artificial Intelligence/Machine Learning-enabled Medical Devices
October 14, 2021

October 14, 2021
10:00 AM - 3:30 PM ET

The Food and Drug Administration (FDA) is announcing a virtual public workshop on transparency of Artificial Intelligence/Machine Learning (AI/ML)-enabled medical devices to patients, caregivers, and providers. The role of transparency that enhances safe and effective use of AI/ML-enabled medical devices will be discussed, with an emphasis on information sharing methods such as labeling. 

The purpose of the workshop is to 1) identify unique considerations in achieving transparency for users of AI/ML-enabled medical devices and ways in which transparency might enhance the safety and effectiveness of these devices; and 2) gather input from various stakeholders on the types of information that would be helpful for a manufacturer to include in the labeling of and public facing information of AI/ML-enabled medical devices, as well as other potential mechanisms for information sharing. 


This workshop builds on the Agency’s longstanding commitment to support innovative work in the regulation of digital health technologies, and is a direct response to stakeholder feedback, including feedback from the Agency’s Patient Engagement Advisory Committee on AI/ML-enabled medical devices held in October 2020. In January 2021, FDA presented a five-part Action Plan focused on AI/ML-enabled medical devices, which included a proposal to hold a public workshop on how information sharing about a device supports transparency to all users of AI/ML-enabled medical devices. This workshop fulfills that proposal, an important aspect of the Action Plan.


This workshop will be held on October 14, 2021, from 10:00 a.m. to 3:30 p.m. (ET) by webcast only. 


The virtual public workshop will be a live webcast and the link will be provided in your confirmation email. The link for the archived webcast will be posted to this webpage for viewing after the public workshop. 


This agenda is preliminary and subject to change. More information will be made available as presenters are confirmed.

Time Subject Name of Speaker
10 a.m. Welcome TBD
10:15 a.m.

I. The Meaning and Role of Transparency

What does transparency mean to different stakeholders of AI/ML-enabled medical devices? 

What information about AI/ML-enabled medical devices is important to each stakeholder for establishing the safety and effectiveness of these products?

Invited talks followed by panel discussion and Q&A

12:00 p.m. Lunch  
12:30 p.m. Open Public Comment Session  
1:20 p.m. Break  
1:30 p.m.

II. Promoting Transparency

What are the current and possible means of  promoting transparency of AI/ML-enabled medical devices to users? What practices are the stakeholders seeing for information sharing, including labeling? What are important areas for future development? 

Invited talks followed by panel discussion and Q&A

3:15 p.m. Closing Remarks  
3:30 p.m. Adjourn  


If you wish to attend this Workshop, you must register by 4:00 p.m. on October 13, 2021.

There is no fee to register for the workshop. Registration will be on a first-come, first-served basis.

Registrants will receive confirmation when requests for participation have been accepted.

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, Susan.Monahan@fda.hhs.gov by September 29, 2021

No dashes or spaces in phone numbers please.


Please submit your comments regarding the workshop to https://www.regulations.gov/, Docket No. FDA-2019-N-1185 by November 15, 2021.  

Please refer to the Instructions for submitting comments to the docket to ensure that your feedback is received.  

The resulting discussions from the workshop and comments received in the docket will be taken into consideration.

Please be advised that as soon as a transcript is available, it will be posted in the Dockets and accessible at http://www.regulations.gov.  


For questions regarding workshop content please contact:

Nooshin Kiarashi, PhD
Center for Devices and Radiological Health
U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
Email: AI-MLTransparencyWorkshop2021@fda.hhs.gov


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