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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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  • 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
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
           

Metal Ion Levels


Suggest Enhancement / Report Issue | Export to ExcelExport to Excel
522
Order
Number
Study
Name
Current
Protocol
Approved
Study
Population
Study Status
Root
Document
Number
PS110005 Metal Ion Levels 06/14/2013 Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21 Progress Adequate K052888
K061423
K062994
K062995
K063002
K063514
K070274
K073637
K062998
K993438
K002379
K011110
K042037
K042774
K042841
K050124
K043547
K082446
K090757
K050251
K050441
K093235
K852351


Metal Ion Levels Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 Month Report 08/20/2012 08/20/2012 On Time
12 month Report 03/29/2013 02/13/2013 On Time
18 month report 08/13/2013 08/14/2013 Overdue/Received
2 yr report 02/12/2014 02/19/2014 Overdue/Received
3 yr report 02/12/2015    
4 yr report 02/12/2016    
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