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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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MiSight 1 Day Safety PAS

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Study Status Progress Inadequate
Application Number P180035 / PAS002
Date Current Protocol Accepted  
Study Name MiSight 1 Day Safety PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Admin Database
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Child: 2-12 yrs

MiSight 1 Day Safety PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
3 month report 02/14/2020 02/13/2020 On Time
six month report 05/15/2020 05/13/2020 On Time
9 month report 08/14/2020 08/14/2020 On Time
one year report 11/14/2020 11/13/2020 On Time
18 month report 05/15/2021 05/14/2021 On Time
two year report 11/14/2021    
three year report 11/14/2022    
four year report 11/14/2023    

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources