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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

DIVISION OF EPIDEMIOLOGY

"PROTECTING & PROMOTING PUBLIC HEALTH THROUGH DEVICE SURVEILLANCE AND RESEARCH"



WELCOME TO THE 522 POSTMARKET SURVEILLANCE STUDIES WEBPAGE

 

 

 

 

            

Cross-Sectional Study


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General
522 Number / Requirement Number PS110093 / PSS001
Current Plan Approved 09/21/2015
Study Name Cross-Sectional Study
Root Document Number K871453  K032348  K033634  K033943  K974728  K003758  K053536  K071723  K091003  K091973  K063251  K071856  K073499  K081007 
General Study Protocol Parameters
Study Design Cross-Sectional Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Cross-sectional study design, new enrollment
Sample Size The sample size is expected to be comprised of 400 males
and females who underwent metal on metal THR within the
last 96 months (range 1-8 years. For baseline measurement of pre-implant whole blood and serum cobalt and chromium ion levels 120 males and females who do not currently have a medical device implant will be enrolled.
Data Collection Study endpoints include adverse events, changes in metal ion concentrations in whole blood and serum over time, radiographic results and any incidence of adverse local tissue reactions that might be linked to metal ion levels or certain patient clinical or demographic characteristics
Follow-up Visits and Length of Follow-up Patients will undergo a one-time cross-sectional assessment, as available by product release date.
Final Study Results
Interim Safety Information N/A
Number of Patients 11


Cross-Sectional Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 06/06/2013 05/15/2013 On Time
1 yr report 12/06/2013 11/25/2013 On Time
18 month report 06/06/2014 06/06/2014 On Time
2 yr report 12/06/2014 12/11/2014 Overdue/Received
3 yr report 12/06/2015 12/09/2015 Overdue/Received
39 month report 06/05/2016    
Final Report 07/06/2016    


  • 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.
  • 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.
  • 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

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-2252
Silver Spring, MD 20993-0002

Phone: (301) 796-7033
Fax: (301) 847-8140
Cheryl.Reynolds@fda.hhs.gov
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