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  5. Public Meeting - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027 - Postponed Until Further Notice - 05/05/2020 - 05/05/2020
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Meeting

Event Title
Public Meeting - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027 - Postponed Until Further Notice
May 5, 2020

Postponed

Date:
May 5, 2020
Time:
9:00 AM - 5:00 PM ET

The Food and Drug Administration public meeting entitled "Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting; Request for Comments" that appeared in the Federal Register on March 6, 2020 (85 FR 13165) and was rescheduled for May 5, 2020 is now postponed until further notice. Please follow the FDA’s website for updates.

If you have questions about this public meeting, contact the Division of Industry and Consumer Education.

The Food and Drug Administration (FDA) is announcing a public meeting on the reauthorization of the Medical Device User Fee Amendments for fiscal years 2023 through 2027 (MDUFA V). The current legislative authority for the medical device user fee program expires on October 1, 2022, and new legislation will be required for the FDA to continue collecting user fees for the medical device program in future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before the FDA begins negotiations with the regulated industry on MDUFA reauthorization, we publish a notice in the Federal Register requesting public input on the reauthorization, hold a public meeting at which the public may present its views on the reauthorization, provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to MDUFA, and publish the comments on the FDA's website.  The FDA invites public comment on the medical device user fee program and suggestions regarding the commitments the FDA should propose for the next reauthorized program.

DATE, TIME, and LOCATION

The public meeting will take place remotely on May 5, 2020, from 9 a.m. to 5 p.m. EST. Submit either electronic or written comments on the medical device user fee program and suggestions regarding the commitments FDA should propose for the next reauthorized program by June 5, 2020.

WEBCAST

The webcast link will be available on the registration web page after April 23, 2020.

AGENDA

The meeting will address the following topics:

  • Welcome and Introduction
  • Review Processes and Performance
  • Building a Sustainable Infrastructure for the Future
  • National Evaluation System for health Technology (NEST)
  • Strengthening the Safety of Medical Devices Across the Total Product Life Cycle
  • Medical Device Industry Perspectives
  • Patient Engagement and the Science of Patient Input
  • Fostering Device Innovation
  • Envisioning the Device Ecosystem in 2027
  • Open Public Comment

The meeting topics are subject to change.

REQUESTS FOR ORAL PRESENTATIONS

During online registration, you may indicate if you wish to present during a public comment session or participate in a specific session, and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. All requests to make oral presentations must be received by the close of registration on April 23, 2020 at 4:00 p.m. (ET), and any presentation materials must be emailed to Ellen Olson (see CONTACT) no later than April 23, 2020 at 4:00 p.m. Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin and will select and notify participants by April 27, 2020. No commercial or promotional material will be permitted to be presented or distributed at the public meeting.

COMMENTS

Please submit your comments regarding the meeting to https://www.regulations.gov/, Docket No. FDA-2020-N-0907 by June 5, 2020.   

Please refer to the Federal Register notice for submitting comments to the docket to ensure that your feedback is received. 

The resulting discussions from the meeting 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 meeting content please contact:

Ellen Olson
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 66, Rm. 1664
Silver Spring, MD 20993
301-796-4322
CDRH-OPEQ-StrategicInitiatives@fda.hhs.gov

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