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.
¿ The incidence of adverse events (AEs) will be assessed at the preferred term (PT) level using the Medical Dictionary for Regulatory Activities (MedDRA) for event categorization. Incidence of AEs will also be assessed by 1) onset time with respect to alarm condition; 2) relationship to endoscopic procedure (Colonoscopy or EGD); 3) relationship to the device (alarm response); and 4) severity.
In the event a case involves an anesthesia professional rescue intervention, a root cause analysis will be performed. In the event a case involves an anesthesia professional rescue intervention, a root cause analysis will be conducted by the sponsor and reviewed by FDA. If the first intervention was determined to be a result of a deficiency related to the training program, the aforementioned Restriction of Use may not be removed. If the first anesthesia professional rescue intervention was determined to be required irrespective of the training program, the study may continue.
If ≥2 interventions by an anesthesia professional occur, the primary endpoint has failed and the Restriction of Use may not be removed.
Consent of subject, procedure type (routine non-emergent colonoscopy or EGD with the SEDASYS System), airway rescue interventions, AEs and product complaints.
Followup Visits and Length of Followup
Adult male and female subjects who satisfy the approved FDA labeling and are scheduled for
non-emergent endoscopy procedures during the study timeframe will be invited to participate in the study. Patients will be enrolled with informed consent including those from companion study (CI-13-
Visit 1: Screening.
Visit 2: Pre-procedure <=15 days of the procedure(Visit 1 (screening) and Visit 2 (procedure) could occur on the same day).
Length of Follow-up
1-day per patient.
Open Label Post Market Registry in Clinical Practi