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U.S. Department of Health and Human Services

Post-Approval Studies

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Post-Approval Studies

  • In January 2005, the oversight responsibility of the Post-Approval 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).
  • The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 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 PAS 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 PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.


Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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Application Number P020014 S017
Current Protocol Accepted 05/12/2016
Study Name OSB Lead-Essure/post-NovaSure PAS
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Single-arm multi-center prospective observational study
Study Population Description Women aged 21-50 with Essure microinserts properly placed

(confirmatory HSG) seeking treatment for menorrhagia.

  show the rest ...
Sample Size A minimum of 220 female subjects relying on Essure micro- inserts seeking treatment for menorrhagia   show the rest ...
Data Collection Occurrence of confirmed pregnancy at 1 year and 3 years among subjects relying on Essure   show the rest ...
Followup Visits and Length of Followup 3 years

One week post Novasure procedure, then one and three year Post-EA Contraception Phone Call

  show the rest ...

OSB Lead-Essure/post-NovaSure PAS Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 08/24/2012 12/14/2012 Overdue/Received
one year report 02/23/2013 03/08/2013 Overdue/Received
18 month report 08/24/2013 09/12/2013 Overdue/Received
two year report 03/21/2014 03/24/2014 Overdue/Received
three year report 02/23/2015 02/27/2015 Overdue/Received
42 month report due 08/23/2015 08/19/2015 On Time
four year report 02/23/2016 02/22/2016 On Time
five year report 02/22/2017    

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