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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

 

 

 

 

            

Explant


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General
522 Number / Requirement Number PS110004 / PSS002
Current Plan Approved 11/25/2013
Study Name Explant
Root Document Number P020016 
General Study Protocol Parameters
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description "This is a study of retrieved explants based on the number of revision cases for which explants are retrieved. This study will evaluate explants retrieved through:

1. a prospective, multi-center trial that enrolls subjects who previously received a Biomet TMJ Replacement System (Study A, PS110004) and who are undergoing a revision procedure;

2. an analysis of explants returned to Biomet through the complaint handling process

3. explants received from all revisions which occur during the survival study (PS110004A) at sites enrolled in the survival study, whether or not revisions came from the survival analysis.

"

Study Population Description 18 to 21 yrs; Adult 21+

Sample Size 20 explanted joints

Data Collection The study endpoints will include analysis of the modes and causes of failure. The potential effect of a subject¿s demographic data, clinical history, or diagnosis on device failure will also be performed.

Follow-up Visits and Length of Follow-up Not applicable



Explant Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 Month Report 10/24/2012 10/24/2012 On Time
1 year report 04/24/2013 04/25/2013 Overdue/Received
18 month report 10/23/2013 10/18/2013 On Time
2 year report 04/24/2014 04/23/2014 On Time
3 year report 04/24/2015 04/23/2015 On Time
Final Report 12/01/2015    


  • 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
WO66-4108
Silver Spring, MD 20993-0002

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