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Boston Scientific, Food & Drug Administration, Hip Replacement, Law firm, Medical device, NephewSmith, New York City, UNited States
Post-Approval Studies for Smith & Nephew BHR – NOT USEFUL
Post-Approval Studies.
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
- 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
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Export to Excel
US Study Schedule
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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
|
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UK Study Schedule
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Show All Studies
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