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.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
Sponsor collects the information for any adverse events and complaints, including those which are not
associated with any adverse clinical effect, received by the company for the BRYAN device following PMA approval.
Study Population Description
Study population is as per device indication.This device is indicated in skeletally mature patients for
reconstruction of the disc from C3-C7 following single-level discectomy for intractable radiculopathy and/or myelopathy.
Sample Size
NA
Data Collection
The primary outcome variable, overall success, is defined below. A patient will be considered an
overall success if all of the following conditions are met:
- Postoperative Neck Disability Index score improvement of at least 15-points from preoperative (score decrease signifies improvement);
- Maintenance or improvement in neurological status from preoperative;
- No serious adverse event classified as implant associated or implant/surgical procedure associated; and
- No additional surgical procedure classified as a "failure". Second surgery "failures" are additional surgeries that occur after the treatment surgery that affect the original device configuration.
Followup Visits and Length of Followup
This reporting occurs at six-month intervals for the first two years of approval and then
continues on an annual basis until five years after PMA approval.
