SUMMARY

The Food and Drug Administration (FDA) is announcing a co-sponsored public conference in collaboration with Advanced Medical Technology Association (AdvaMed) entitled “FDA/AdvaMed Medical Device Statistical Issues (MDSI) Conference.”  The co-sponsored public conference is aimed to share information on the recent and future developments of statistical methodology and practice in the evaluation of safe and effective medical products with stakeholders. The purpose of the conference is to facilitate clinical trial innovations and advance regulatory statistical science for diagnostics and medical devices. 

Background

The FDA’s Center for Devices and Radiological Health (CDRH) in collaboration with AdvaMed Events and Education (AE&E) is organizing this co-sponsored public conference to offer unique training and educational needs of the medical device/diagnostic industries concerning statistics for a broad range of regulated companies by providing information on current statistical methodologies.  The co-sponsored public conference will highlight clinical trial innovations and advance regulatory statistical science for diagnostics and medical devices. The co-sponsored public conference hopes to bring together the device industry, academia, and FDA/CDRH to exchange perspectives and find solutions to shared challenges. The planned co-sponsored public conference is open to all including medical device statisticians and other interested parties.

• Date, Time, and Location
• Preliminary Agenda
• Registration
• Contact

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DATE, TIME and LOCATION

The co-sponsored public conference will be held on April 2, 2024, from 8:45 a.m. to 6:00 p.m and April 3, 2024, from 8:00 a.m. to 4:00 p.m. at the following location: 

J.W. Marriott, 1331 Pennsylvania Avenue NW, Washington, DC 20004.

Link for the hotel J.W. Marriott: https://www.marriott.com/en-us/hotels/wasjw-jw-marriott-washington-dc/overview/

AGENDA

The Agenda is available at the registration website https://www.advamed.org/wp-content/uploads/2024/03/Updated_3.7.24_FDA_AdvaMed-Statistical-Issues-Conference-Agenda.pdf

REGISTRATION

If you wish to attend this co-sponsored public conference, you must register by April 2, 2024.  Registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited. For registration, please visit: FDA/AdvaMed Medical Device Statistical Issues (MDSI) Conference - AdvaMed 

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, [email protected].

CONTACT

For questions regarding this co-sponsored public conference content please contact:

Rajesh Nair 
Assistant Director for Biostatistics 4 Division of Clinical Evidence and Analysis 2 (Biostatistics) 
Office of Product Evaluation and Quality CDRH 
10903 New Hampshire Ave Silver Spring, MD 20903 
(301) 796-6021 phone 
[email protected]