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The Food and Drug Administration (FDA) is announcing a virtual public workshop entitled “Building Medical Device Supply Chain Resilience: A Healthcare and Public Health Ecosystem-Wide Collaboration.” The purpose of the public workshop is to discuss ways to foster resiliency in the medical device supply chain and to seek input on the new Resilient Supply Chain Program (RSCP). The RSCP aims to build upon a foundation of strong partnerships to improve supply chain resiliency through proactive communication, collaboration, and engagement with patient advocates, health care providers, distributors, group purchasing organizations, manufacturers, as well as key component and material suppliers.

• Background
• Date and Time
• Webcast
• Preliminary Agenda
• Registration
• Comments
• Contact

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BACKGROUND

The Resilient Supply Chain Program (RSCP) is currently being established within the Center for Devices and Radiological Health (CDRH). The RSCP’s mission is to strengthen public health supply chains by proactively monitoring, assessing, and communicating risks and vulnerabilities to help prevent and mitigate shortages of medical devices. The purpose of the public workshop is to introduce the RSCP, explore opportunities to collaborate on enhancing resilience within the medical device supply chain, and solicit public feedback. 

Topics for discussion include:

• Resiliency in the medical device supply chain 
  • Perspectives across the medical device ecosystem 
• Methods to measure resiliency
• Collaboration with government, private sector, and non-governmental organizations to build and sustain resilience 
  • Novel pre- and post-market mitigation strategies 
  • Measures to identify and prevent potential supply chain disruptions to prevent shortages
  • Potential response structures to mitigate future challenges

The FDA hopes to use the learnings and key takeaways from the panel discussions, breakout sessions, and comments received to further development of the RSCP, and may use such learnings in future activities, including discussion papers. 

DATE and TIME

This public workshop will be held June 7-9, 2022, from 1:00 PM to 4:00 PM (ET) by webcast only. 

WEBCAST

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

PRELIMINARY AGENDA

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

REGISTRATION

If you wish to attend this Workshop, you must register by 4:00 p.m. on June 6, 2022.

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

FDA is seeking interested stakeholders to participate in the breakout sessions during this event. If interested, please note (Yes) in the registration field (#7). Space is limited for the breakout sessions, so FDA may limit the number of participants from each organization. If you wish to participate in the breakout sessions, registration must be completed by 4:00 p.m. on May 17, 2022. 

There is no fee to register for the workshop or breakout groups.

Register for This Event

Registrants will receive confirmation when requests for participation have been accepted, if applicable. Registrants who have requested to participate in breakout sessions will receive a separate notification confirming acceptance with details on how to access the breakout sessions.

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.

COMMENTS

Please submit your comments regarding the workshop to https://www.regulations.gov, Docket No. FDA-2022-N-0593 by July 11, 2022.

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.  

CONTACT

For questions regarding workshop content please contact:

Tammy Beckham,  
Associate Director, Resilient Supply Chain & Shortages Program (RSCP)
Center for Devices and Radiological Health (CDRH)
Office of Strategic Partnerships and Technology Innovation (OST)
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
Email: RSCPWorkshop@fda.hhs.gov