Post-Approval Studies (PAS) Database

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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FreeStyle Libre Flash Glucose Monitoring PAS

General
Study Status	Delayed
Application Number / Requirement Number	P160030 / PAS001
Date Original Protocol Accepted	12/08/2017
Date Current Protocol Accepted	04/05/2024
Study Name	FreeStyle Libre Flash Glucose Monitoring PAS
Device Name	Freestyle Libre Flash Glucose Monitoring System
Clinical Trial Number(s)	NCT02082184 NCT02232698 NCT02283411 NCT02388815
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	New Data Collection
Comparison Group	Historical Control
Analysis Type	Analytical
Study Population	Adolescent: 13-18 yrs, Transit.Adolescent B(as adults): 18 yrs < 22 yrs, Adult: At least 22 yrs
Interim or Final Data Summary
Interim Results	Safety Results: Compared to the previous 48-month report, there was no change in the number of primary endpoints adverse events for severe hypoglycemia and moderate hypoglycemia (6 months historical medical record data). Twenty-one (21) subjects had severe hypoglycemia (observed in 28 events) and eighteen (18) subjects had moderate hypoglycemia (observed in 28 events) based on 6 months of medical record data. In the intervention phase, one subject had severe hypoglycemia (observed in one event) and compared to the last 48-month report, there was one additional subject for a total of four (4) subjects that had moderate hypoglycemia (observed in 4 events), and none of these events were device related. Effectiveness Results:
Actual Number of Patients Enrolled	184
Actual Number of Sites Enrolled	13
Patient Follow-up Rate	Out of the 184 subjects enrolled in the Intervention Phase, 7 withdrew consent, 2 were removed due to screening failure, 1 was discontinued from the study due to protocol deviation, 4 elected to discontinue participation in the study, and 1 was removed due to an adverse event. Forty (40) subjects were lost to follow-up. In all these cases, the subject either did not show up to a study visit and/or became unreachable. Multiple attempts, including phone calls, emails, and text messages, were made to locate each subject with no success.

FreeStyle Libre Flash Glucose Monitoring PAS Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
6 month report	03/28/2018	03/26/2018	On Time
1 year report	09/27/2018	09/17/2018	On Time
18 month report	03/28/2019	03/28/2019	On Time
2 year report	09/27/2019	09/20/2019	On Time
3 year report	09/26/2020	09/22/2020	On Time
final report	05/19/2021	05/19/2021	On Time
6 month report	05/25/2022	05/25/2022	On Time
1 year report	11/25/2022	11/22/2022	On Time
18 month report	06/23/2023	06/23/2023	On Time
2 year report	12/23/2023	12/18/2023	On Time
30 month report	06/23/2024	06/21/2024	On Time
3 year report	12/23/2024	12/23/2024	On Time
42 month report	06/23/2025	06/20/2025	On Time
4 year report	12/23/2025	12/19/2025	On Time
54 month report	06/23/2026	06/23/2026	On Time
5 year report	12/23/2026

Contact Us

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

Additional Resources

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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background