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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.

Links

Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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General
Application Number P040046
Study Name Natrelle 410 US-PAS
Study Status Study Pending
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 Prospective cohort study (two arms, i.e., patients receive Natrelle

410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast   show the rest ...
Study Population Description Women who are implanted with the Natrelle Highly Cohesive Silicone-Filled Breast Implants for augmentation or   show the rest ...
Sample Size 2,287 women with the Natrelle Highly Cohesive Silicone-Filled

Breast Implants and 300 women with Natrelle Saline   show the rest ...
Data Collection The effectiveness endpoints are subject satisfaction with breasts and psychosocial well-being measured using the BREAST-Q.

The   show the rest ...
Followup Visits and Length of Followup Patients will be followed for 10 years.

Patients will complete questionnaires annually. There will be   show the rest ...


Natrelle 410 US-PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
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    
3 year report 02/20/2016    
4 year report 02/19/2017    
5 year report 02/19/2018    

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