Post-Approval Studies for Smith & Nephew BHR – NOT USEFUL

Post-Approval Studies.

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
• Tools for Conducting PAS
  • Letter to IRB Chairs (formerly referred to as “IRB Letter from Dr. Schultz (dated 2/9/09)”
  • Letter to PAS Participants
  • Letter to PAS Investigators
• Post-Approval Studies Workshops
  • Report on Implementation of Post-Approval Studies for Medical Devices Workshop (June 2009)

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

Show All Studies Export to Excel General Application Number P040033 Protocol Approved 05/09/2006 Study Name US Study Study Status Progress Adequate 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 No Control Analysis Type Analytical Study Population Transitional Adolescent B: 18-21 yrs, Adult: >21 Detailed Study Protocol Parameters Study Design Description The study design is a multi-center, single arm, prospective cohort study. Study Population Description Study population is as per device indication. Patients who underwent Birmingham Hip Resurfacing (BHR) System,    Sample Size The sample size is 350 patients. Data Collection Study endpoints include Harris Hip Score and device survival. Followup Visits and Length of Followup Patients will undergo clinical and radiographic examinations for the first five years of follow-up with

US Study Schedule

Report Schedule Report Date Due FDA Receipt Date Reporting Status 6 month report 11/07/2006 11/13/2006 Overdue/Received 1 year report 05/09/2007 05/08/2007 On Time 18 month report 11/07/2007 11/05/2007 On Time 2 year report 05/08/2008 05/06/2008 On Time 3 year report 07/08/2009 07/06/2009 On Time 4 year report 05/08/2010 05/06/2010 On Time 5 year report 07/07/2011 08/29/2011 Overdue/Received 6 year report 05/07/2012 05/07/2012 On Time 7 year report 05/07/2013 8 year report 05/07/2014 9 year report 05/07/2015 10 year report 05/06/2016

Show All Studies

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
• Tools for Conducting PAS
  • Letter to IRB Chairs (formerly referred to as “IRB Letter from Dr. Schultz (dated 2/9/09)”
  • Letter to PAS Participants
  • Letter to PAS Investigators
• Post-Approval Studies Workshops
  • Report on Implementation of Post-Approval Studies for Medical Devices Workshop (June 2009)

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

Show All Studies Export to Excel General Application Number P040033 Protocol Approved 05/09/2006 Study Name UK Study Study Status Progress Adequate 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 No Control Analysis Type Analytical Study Population Transitional Adolescent B: 18-21 yrs, Adult: >21 Detailed Study Protocol Parameters Study Design Description The study design is a single arm, cohort study. Study Population Description Study population is as per device indication. Patients who underwent Birmingham Hip Resurfacing (BHR) System,    Sample Size The sample size is 350 patients. Data Collection Study endpoints include OSHIP scores and device survival. Followup Visits and Length of Followup At the time of PMA submission, all subjects had passed their 5 year post-implantation anniversary.

UK Study Schedule

Report Schedule Report Date Due FDA Receipt Date Reporting Status 2 year report 05/22/2008 05/16/2008 On Time 3 year report 07/08/2009 07/06/2009 On Time 4 year report 05/08/2010 05/06/2010 On Time 5 year report-final report 07/07/2011 07/05/2011 On Time 6 year report 05/07/2012 Overdue

Show All Studies

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