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.
Transit. Adolescent B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
Study Objectives- to fully characterize adverse events and
complaints when the device is used in the
intended use population in the United States and in the rest of the world. Medtronic will attempt to collect the following information for any adverse events and complaints, including those complaints which are not associated with any adverse clinical effect. Design-enhanced surveillance
Study Population Description
All device users
All adverse event data including subsequent surgeries, heterotopic ossification, device malfunction, and other serious device-related
complications. Information will be actively collected from annual surgeon surveys and on the company website. Information will also be collected passively through complaints, MDRs, and annual systematic literature reviews.
All of the surgeons who have been trained on the use of PRESTIGE® LP Cervical Disc Prosthesis in the U.S. will be surveyed annually and the number of surveys issued and received will be reported. If a survey response includes any information related to an adverse event, you will collect additional data as specifically outlined in the ESS protocol and report that data to FDA.