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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

 

 

 

 

            

Fusion, AEs, Surg Procedures


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General
522 Number / Requirement Number PS090016 / PSS001
Current Plan Approved 11/05/2012
Study Name Fusion, AEs, Surg Procedures
Root Document Number K031511  K071879  K071880 
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 prospective observationalone arm cohort study. The fusion rate will be compared to the fusion rate

reported in the literature. The hypothesis is that the Dynesys fusion rate at 24 months is noninferior to the historical literature sample data estimated fusion rate of 80.6%, with 0.1 of noninferiority margin."

Study Population Description The study population is comprised of patients who receive Dynesys Spinal System and meet the inclusion/exclusion criteria are eligible for enrollment.
Sample Size sites-6, patients 168

Data Collection Fusion, adverse events and surgical procedures
Follow-up Visits and Length of Follow-up The scheduled visits are planned at 6 months ± 4 weeks, 12 months, 24 months, and Annual Visits after 24 month until all patients have completed the study (± 8 weeks)
Final Study Results
Interim Safety Information Based on the assessed information no new risk associated with the device were identified.


Fusion, AEs, Surg Procedures Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 Month Report 10/02/2011 10/04/2011 Overdue/Received
1 year report 04/03/2012 04/02/2012 On Time
18 month report 11/30/2012 10/03/2012 On Time
2 yr report 04/02/2013 04/02/2013 On Time
3 yr report 04/02/2014 04/02/2014 On Time
4 yr report 04/02/2015 04/03/2015 Overdue/Received
54 month report 10/02/2015    
66 month report 01/02/2016    
5 yr report 04/02/2016    
6 year report 04/03/2017    
7 yr report 04/03/2018    
Final Report 09/02/2018    


  • 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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