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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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ReWalk RWE Study


 
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General
Study Status Progress Adequate
522 Number / Requirement Number PS140001 / PSS002
Date Current Plan Accepted  
Study Name ReWalk RWE Study
Root Document Number
General Study Protocol Parameters
Study Population


ReWalk RWE Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
51 month report 09/13/2020 09/15/2020 On Time
54 month report 12/12/2020 12/14/2020 On Time
57 month report 03/12/2021 03/05/2021 On Time
60 month report 06/10/2021   Overdue
63 month report 09/08/2021    
66 month report 12/07/2021    


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