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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

 

 

 

 

            

ReWalk Registry


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General
Study Status Progress Inadequate
522 Number / Requirement Number PS140001 / PSS001
Current Plan Approved 05/19/2017
Study Name ReWalk Registry
Root Document Number K131798 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description New enrollment long-term, prospective, non- interventional multi-center, observational study
Study Population Description Device group: patients with Spinal Cord Injury and their companions; Comparison group: None.



Sample Size The targeted sample size is 60 subjects (with 60 companions) to be recruited from up to 12 U.S. clinical sites. The sample size is not determined based on a specific hypothesis to be tested since the study is not hypothesis- driven.
Data Collection Long-term safety of the ReWalk Personal Device for Subjects in institutional and non-institutional environments, as measured by 12- month incidence of all Serious Adverse Events in Subjects;

• Long-term safety of the ReWalk Personal Device for Subjects in institutional and non-institutional environments, as measured by 12- month incidence of falls and fall-associated injuries;

• Long-term safety of the ReWalk Personal Device for Companions in institutional and non-institutional environments, as measured by 12- month incidence of all Serious Adverse Events in Companions;

• Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, as measured by the proportion of Subjects enrolled in training who successfully complete the intended training;

• Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, as measured by the proportion of Subjects who successfully completed the intended training who are able to demonstrate proficiencies at 12 months after completion of the intended training;

• Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, as measured by the Subjects’ abilities to navigate surfaces and environments outside of the institutional environment in accordance with their training;

• Adequacy of the Multi-Tiered Training Program of the ReWalk

Personal Device for Companions, as measured by the proportion of

Companions enrolled in training who successfully complete the intended training;
Follow-up Visits and Length of Follow-up Consecutive enrollment at up to 12 US centers

12 months


ReWalk Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 month report 06/06/2016 07/13/2016 Overdue/Received
2 month report 07/05/2016 08/15/2016 Overdue/Received
3 month report 09/15/2016 09/15/2016 On Time
4 month report 10/15/2016 10/12/2016 On Time
5 month report 11/15/2016 11/07/2016 On Time
6 month report 12/15/2016 12/02/2016 On Time
7 month report 01/15/2017 12/29/2016 On Time
8 month report 02/15/2017 01/31/2017 On Time
9 month report 03/15/2017 03/01/2017 On Time
10 month report 04/15/2017 04/03/2017 On Time
11 month report 05/15/2017 05/15/2017 On Time
1 year report 06/15/2017 06/14/2017 On Time
18 month report 12/14/2017    
2 year report 06/15/2018    
3 year report 06/15/2019    
4 year report 06/15/2020    


  • 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) 796-6068
Fax: (301) 847-8140
Cheryl.Reynolds@fda.hhs.gov
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