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.
A negative HPV result predicted a lower 3-year risk of ¡ÝCIN3 than did a negative
cytology result. The low 3-year (cumulative incidence ratio) CIR for a negative HPV result also confirmed the safety of a 3-year interval for HPV primary screening. The follow-up study confirmed the continued high risk of HPV16 or HPV18 infection, with the observation that 1 in 4 women who tested HPV 16+ at Baseline and 1 in 9 who tested HPV18+ at Baseline were diagnosed with ¡ÝCIN3 within 3 years. The follow-up data for the NILM population ¡Ý30 years demostrated safety over 3 years of a negative HPV test at Baseline in the context of adjunct testing. In addition, the data demonstrated a higher risk associated with HPV16+ or HPV18+ results (9.56%).
Study Strengths and Weaknesses
Strengths: Large sample size, high compliance at all follow up years, compliance with exit colposcopy was
88%. Weaknesses: Comparisons of cumulative Incidence rate (CIRs) of high-grade cervical disease between subjects with a positive and those with a negative Cobas HPV tests is only limited to up to 3 years.
Recommendations for Labeling Changes
Labeling incorporating the long term Post approval study were submitted and approved