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 P020056 1) CORE POSTAPPROVAL STUDY. YOU MUST CONTINUE YOUR CORE STUDY UNTIL ALL PATIENTS HAVE COMPLETED THEIR 10-YEAR EVALUATION IN ORDER TO ASSESS THE LONG-TERM CLINICAL PERFORMANCE OF YOUR PRODUCT. DATA ARE TO BE COLLECTED VIA ANNUAL PHYSICIAN FOLLOW-UP EVALUATIONS. THE PRIMARY CHANGES TO THE PROTOCOL FROM PREMARKET TO POSTAPPROVAL ARE THAT ALL NON-MRI PATIENTS WILL HAVE A MRI AT YEARS 7 AND 9 AND THAT ALL PATIENTS WHO WERE EXPLANTED WITHOUT REPLACEMENT WILL BE EVALUATED THROUGH 10 YEARS, AS PER THE PROTOCOL. YOU MUST ALSO UPDATE YOUR PATIENT AND PHYSICIAN LABELING TO REFLECT 5 AND 10-YEAR CORE STUDY FINDINGS, AS SOON AS THESE DATA ARE AVAILABLE, AS WELL AS ANY OTHER TIMEPOINT DEEMED NECESSARY BY FDA IF SIGNIFICANTLY NEW INFORMATION FROM THIS STUDY BECOMES AVAILABLE. 2) LARGE POST-APPROVAL STUDY. YOU MUST CONDUCT THE 10-YEAR LARGE POSTAPPROVAL STUDY, AS PER THE PROTOCOL THAT WAS SUBMITTED TO FDA ON OCTOBER 16, 2006. THIS STUDY, WHICH WILL BEGIN PATIENT ENROLLMENT WITHIN 90 DAYS AFTER PMA APPROVAL, WILL BE A SEPARATE STUDY FROM THE CORE STUDY AND WILL INCLUDE 39,390 ALLERGAN SILICONE GEL PATIENTS AND 19,605 SALINE-FILLED BREAST IMPLANT PATIENTS AS THE CONTROL GROUP. THE PURPOSE OF THIS STUDY IS TO ADDRESS SPECIFIC ISSUES FOR WHICH THE CORE STUDY WAS NOT DESIGNED TO FULLY ANSWER, AS WELL AS TO PROVIDE A REAL-WORLD ASSESSMENT OF SOME ENDPOINTS. THE ENDPOINTS IN THE LARGE POSTAPPROVAL STUDY INCLUDE LONG-TERM LOCAL COMPLICATIONS, CONNECTIVE TISSUE DISEASE (CTD), CTD SIGNS AND SYMPTOMS, NEUROLOGICAL DISEASE, NEUROLOGICAL SIGNS AND SYMPTOMS, OFFSPRING ISSUES, REPRODUCTIVE ISSUES, LACTATION ISSUES, CANCER, SUICIDE, MAMMOGRAPHY ISSUES, AND MRI COMPLIANCE AND RUPTURE RESULTS. (SEE APPROVAL ORDER FOR ADDITIONAL CONDITIONS...)   BIFS (Large PAS) 11/17/2006 Adolescent: 13-18 yrs, Transitional Adolescent B: 18-21 yrs, Adult: >21 Progress Inadequate Core 11/17/2006 Adolescent: 13-18 yrs, Transitional Adolescent B: 18-21 yrs, Adult: >21 Progress Adequate Adjunct 11/17/2006 Adolescent: 13-18 yrs, Transitional Adolescent B: 18-21 yrs, Adult: >21 Progress Adequate Device failure Study 11/17/2006 Adolescent: 13-18 yrs, Transitional Adolescent B: 18-21 yrs, Adult: >21 Progress Adequate Informed Decision Process 10/17/2006 Adolescent: 13-18 yrs, Transitional Adolescent B: 18-21 yrs, Adult: >21 Progress Adequate

BIFS (Large PAS) Schedule

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