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U.S. Department of Health and Human Services

Medical Devices

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Public Workshop - Design and Methodology for Postmarket Surveillance Studies under Section 522 of the Federal Food, Drug and Cosmetic Act, March 7, 2012

The Food and Drug Administration (FDA) is announcing a public Workshop entitled “Design and Methodology for Postmarket Surveillance Studies under Section 522 of the Federal Food, Drug and Cosmetic Act.” This workshop is open to all interested parties, including professionals in the scientific community interested in advancing the infrastructure and methodology for postmarket surveillance studies.

The purpose of the workshop is to provide a forum for discussion among FDA, industry, governmental agencies, academia, clinicians and various stakeholders with experience in epidemiology, statistics, and biomedical research to advance the design and methodologies for medical device surveillance studies in the “postmarket” setting, i.e., after FDA premarket approval or clearance of the device and marketing of the device has begun.

Date, Time and Location

This meeting was held March 7, 2012, beginning at 8:00 am - 5:30 pm at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center (Great Room, Room 1503)
Silver Spring, MD 20993

This workshop was webcast.

Webcast Archive

Transcript

Agenda

Design and Methodology for Postmarket Surveillance Studies under Section 522 of the Federal Food, Drug and Cosmetic Act
March 7, 2012
FDA White Oak Conference Center, Building 31 Great Room
Silver Spring, MD

Meeting Agenda

8:00amCall to Order and Introductions
8:05Welcome Remarks
8:15Goals for the Day
Total Product Life Cycle Approach and Its Application to Postmarket Surveillance Studies
8:30Overview of 522 Regulations
8:45Process for Implementing 522 Regulations
9:00Signals, Signal Management, and the 522 Option
9:15Q & A for Regulations
Challenges and Opportunities for Collaborative Efforts
10:00Premarket FDA Perspective – Potential 522 Questions that Arise – Challenges and Opportunities to Collaborate when Additional Data Needed
10:10Postmarket FDA Perspective – Potential 522 Questions that Arise – Challenges and Opportunities to Collaborate when Additional Data Needed
10:20Industry Perspective – Potential 522 Questions that Arise – Challenges and Opportunities to Collaborate when Additional Data Needed
Break10:30-10:45
10:45International Perspective – NJR Registry Collaboration with Regulatory Agencies
10:55Academic/Researcher Perspective –Challenges and Opportunities to Collaborate when Additional Data Needed
11:05Society Perspective – Challenges and Opportunities to Collaborate when Additional Data Needed
11:15Panel Discussion: Challenges and Opportunities for Collaborative Efforts
Lunch12:00-1:00
Role of Networks, Registries, and Observational Studies
1:00TMJ Registry
1:15ACC/STS as example of Registries and Collaborative Registry Development
1:30Medtronic PAN
1:45Recommendations from FDA – Design and Methodologies to Leverage Data Sources
2:00Panel Discussion: Role of Networks, Registries, and Observational Studies
Break2:45-3:00
Methodologies and Scientific Infrastructure to Promote Innovation
3:00Overview of ICOR and IDEAL
3:15Leveraging Use of EHR/Claims Data
3:30Linking Data Sources, Hybrid Designs
3:45Evidence Synthesis
 Recommendations from FDA – Design and Methodologies to Leverage Methodologies
4:00Panel Discussion: Methodologies and Scientific Infrastructure to Promote Innovation
Moving Forward with 522, Next Steps and Vision
4:45Next Steps and Vision

Contacts

For questions regarding workshop content please contact:

Samantha Jacobs
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 66, rm. 4201C
Silver Spring, MD 20993
301-796-6897
e-mail: samantha.jacobs@fda.hhs.gov

or

Mary Beth Ritchey
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 66, rm. 4118,
Silver Spring, MD 20993
301-796-6638
e-mail: maryelizabeth.ritchey@fda.hhs.gov