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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 P060028
Current Protocol Accepted 06/14/2013
Study Name Post-Approval PMA Cohort Study (PACS)
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The MemoryShape Core Study is a post-approval cohort study to assess safety and effectiveness in   show the rest ...
Study Population Description Women with Mentor¿s MemoryShape Breast Implants as indicated for primary augmentation, revision augmentation, primary reconstruction,   show the rest ...
Sample Size A total of 955 subjects have been enrolled in MemoryShape Core Study. The protocol does   show the rest ...
Data Collection During the 10-year follow-up period, long-term safety of the Implants will continue to be measured   show the rest ...
Followup Visits and Length of Followup Subjects will be seen by the investigator in the investigator's office once a year until   show the rest ...


Post-Approval PMA Cohort Study (PACS) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
Device Retrieval report 06/14/2014 06/09/2014 On Time
one year report 06/14/2014 06/12/2014 On Time
two year report 06/14/2015    
three year report 06/13/2016    
four year report 06/13/2017    
five year report 06/13/2018    

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