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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

 

 

 

 

            

Time to Revision and Explant Analysis


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General
522 Number / Requirement Number PS110003 / PSS001
Current Plan Approved 05/01/2013
Study Name Time to Revision and Explant Analysis
Root Document Number P980052 
General Study Protocol Parameters
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Objective 1: Survival Analysis- Prospective Cohort. To determine the survival rate for revision and/or removal of TMJ Concepts implants and use this data to determine factors that affect this survival during three years of follow-up. This will answer questions 1-3 and question 5b. Objective 2: Reason for Failure Analysis-cross-sectional study. To determine the reasons for TMJ implant revisions and removals among patients who have had TMJ Concepts implants. This will answer question 4. Objective 3: Explant Analysis. To determine the specific modes and causes of failure based on an analysis of all reasonably available explanted retrieved TMJ Concepts devices. This will answer question 5a.

Study Population Description 18 to 21 yrs; Adult 21+

Sample Size 672 patients

Data Collection 1. Survival Analysis: Revision or removal at three years of follow-up; Revision or removal for subgroups of patients. 2. Reason for failure analysis: Reasons for initial and subsequent revision or removal. 3. Explant Analysis; TMJ implant failure.

Follow-up Visits and Length of Follow-up FU Visits: Annually; Length of FU: 3 years



Time to Revision and Explant Analysis Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 10/01/2013 11/13/2013 Overdue/Received
12 month report 04/01/2014 03/31/2014 On Time
18 month report 09/30/2014 09/30/2014 On Time
2 year report 04/01/2015 04/02/2015 Overdue/Received
3 year report 04/01/2016    
4 year report 04/03/2017    
Final Report 12/01/2017    


  • 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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