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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
522 Number / Requirement Number PS140001 / PSS001
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 This is a long-term, prospective, non-interventional, multicenter study of

approximately 24 months duration to monitor safety and training in patients with spinal cord injuries and their trained companions who have been recently initiated with the ReWalk Personal Device

Study Population Description For use in institutional and non-institutional environments: Subjects with spinal cord injury at levels T7 to L5.

• Age = 18 years old;

• Hands and shoulders can support crutches or a walker;

• Healthy bone density;

• Skeleton does not suffer from any fractures;

• Able to stand using a device such as EasyStand;

• In general good health;

• Height is between 160 cm and 190 cm (5’3” – 6’2”);

• Weight does not exceed 100 kg (220 lbs);

• Proficiency in spoken and written English language.

Sample Size 60 subjects
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 08/04/2016 09/15/2016 Overdue/Received
4 month report 09/03/2016   Overdue
5 month report 10/03/2016    
6 month report 11/02/2016    
7 month report 12/02/2016    
8 month report 01/01/2017    
9 month report 01/31/2017    
10 month report 03/02/2017    
1 year report 05/06/2017    
11 month report 06/01/2017    
18 month report 11/04/2017    
2 year report 05/06/2018    
3 year report 05/06/2019    
4 year report 05/05/2020    


  • 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
WO66-4108
Silver Spring, MD 20993-0002

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