Post-Approval Studies

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

• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Webpage FAQs
• IRB Letter from Dr. Schultz (dated 2/9/09)

Contact Information

Nicole Jones
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4108
Silver Spring, MD
20993-0002

Phone: (301) 796-6062
Fax: (301) 847-8140
nicole.jones@fda.hhs.gov

Show All Studies Export to Excel Application Number Post-Approval Study Commitment Study Name Protocol Approved Study Population Study Status P040036 IN ACCORDANCE WITH THE STUDY PROTOCOL SUBMITTED AUGUST 4, 2006, YOU WILL ENROLL 249 SUBJECTS IN A CONDITION OF APPROVAL STUDY. THE PURPOSE OF THIS STUDY IS (1) TO CONFIRM THE POINT ESTIMATES OF SAFETY AND EFFECTIVENESS AT ADDITIONAL CENTERS TO MORE COMPLETELY CHARACTERIZE THE GENERALIZABILY OF THE PREMARKET CLINICAL DATA TO THE BROADENED CLINICAL POPULATION; (2) TO PROSPECTIVELY MEASURE 12-MONTH MORTALITY AND DETERMINE WHETHER A PATIENT POPULATION WITH A LOW LEFT VENTRICULAR EJECTION FRACTION (LVEF < 30%) IS AT GREATER RISK OF DEATH; AND (3) TO DETERMINE THE LONG-TERM (3 YEARS) EFFECT OF VT ABLATION ON CARDIAC FUNCTION. YOU HAVE AGREED TO PROVIDE QUARTERLY REPORTS OF THE STUDY PROGRESS IN ADDITION TO THE ANNUAL REPORTS SPECIFIED IN THE CONDITIONS OF APPROVAL.   NaviStar Study 08/11/2006 Transitional Adolescent B: 18-21 yrs, Adult: >21 Progress Adequate

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