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
The study design is enhanced surveillance.
Study Population Description
Skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to
C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space.
The sample size is comprised of all patients who receive the device after its approval.
All US physicians who utilize the device will be surveyed.
Subsequent surgeries, heterotopic ossification, and other device related adverse events
Followup Visits and Length of Followup
Surgeons will be surveyed on an annual basis and for ten (10) years from the PMA approval date.