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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 P100012
Current Protocol Accepted 04/10/2013
Study Name PCM Cervical Enhanced Surveillance
Study Status Progress Inadequate
Study Progress Reason Other reason
General Study Protocol Parameters
Study Design Enhanced Surveillance
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Enhanced surveillance
Study Population Description Patients who receive the NuVasive PCM cervical disc in the post-market


Sample Size All physicians who utilize the disc will be solicited for participation
Data Collection Include secondary surgeries, heterotopic ossification, adjacent disc


Followup Visits and Length of Followup Study will be conducted for 10 years after device approval.

Per clinician.

PCM Cervical Enhanced Surveillance Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 04/26/2013 04/24/2013 On Time
one year report 10/26/2013 10/25/2013 On Time
18 month report 04/26/2014 04/24/2014 On Time
two year report 10/26/2014 10/21/2014 On Time
three year report 10/26/2015    
four year report 10/25/2016    
five year report 10/25/2017    

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