• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

  • Print
  • Share
  • E-mail
-

522 Postmarket Surveillance Studies

  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH). DEPI continues to build the 522 program.
  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Nathan S. Ivey, PhD
Senior Scientific Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4278
Silver Spring, MD 20993-0002

Phone: (301) 796-7033
Fax: (301) 847-8140
Nathan.Ivey@fda.hhs.gov
Show All Studies
Suggest Enhancement / Report Issue  Export to ExcelExport to Excel
522
Application
Number
Study
Name
Most Recent
Plan Version
Approved
Study
Population
Study Status
PS090011 Fusion, AEs, Surg Procedures 02/13/2012 Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21 Progress Inadequate


Fusion, AEs, Surg Procedures Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 10/28/2011 02/03/2012 Overdue/Received
1 year report 04/28/2012 06/21/2012 Overdue/Received
18 month report 10/27/2012 10/22/2012 On Time
2 yr report 04/27/2013 04/29/2013 Overdue/Received
30 month report 10/27/2013 10/31/2013 Overdue/Received
3 yr report 04/27/2014    
3 1/2 yr report 10/27/2014    

Show All Studies

-
-