FDA 483 - Englewood Hospital and Medical Center IRB - November 26, 2019

An FDA Form 483 was issued to Englewood Hospital and Medical Center IRB following an inspection conducted from November 22 to 26, 2019. The primary observation highlighted the Institutional Review Board's failure to follow its own written procedures regarding the initial review of medical device studies. Specifically, for four investigational medical device studies (E-14-577, E-14-580, E-15-584, and E-17-690), the IRB's meeting minutes did not document a determination of whether the devices posed a Significant Risk (SR) or Non-Significant Risk (NSR). This omission directly violated their Institutional Review Board, Policies and Procedures Manual, which requires such a determination when the FDA has not yet made one. This observation, issued pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, serves to assist the firm in complying with applicable regulations. While the Form 483 itself is an observation report and not a final determination of compliance, it requires the Englewood Hospital and Medical Center IRB to respond by discussing any objections or outlining planned corrective actions to ensure proper adherence to their established protocols for device review and regulatory compliance.