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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 P040046
Current Protocol Accepted 08/25/2016
Study Name OSB Lead-Natrelle and 410 Combined Cohort
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 Concurrent & Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is designed to address postmarket questions for both Natrelle (P020056) and Natrelle 410   show the rest ...
Study Population Description Women implanted with Allergan Natrelle silicone breast implants and Natrelle 410 highly cohesive silicone breast   show the rest ...
Sample Size 2,000 subjects with Allergan Round Responsive silicone gel쳌] filled breast implants and 245 subjects with   show the rest ...
Data Collection Adverse events (including local complications, less rare connective tissue diseases, rheumatologic and neurologic signs and   show the rest ...
Followup Visits and Length of Followup 10 years.

Subject questionnaire will be collected annually. Office visits at Year 1, 4 and 10   show the rest ...

OSB Lead-Natrelle and 410 Combined Cohort Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 08/21/2013 08/20/2013 On Time
one year report 02/20/2014 02/18/2014 On Time
18 month report 08/27/2014 08/27/2014 On Time
two year report 02/20/2015 02/20/2015 On Time
6 month report (new study) 02/03/2016 02/03/2016 On Time
1 year report 08/03/2016 08/02/2016 On Time
18 month report 02/03/2017    
2 year report 08/03/2017    

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