The new guidelines call for firms making drug-device combinations to submit individual case reports to the FDA’s Adverse Events Reporting System and electronic Medical Device Reporting system by July 31, 2020. Vaccine adverse event reports are due Jan. 31, 2021, the FDA said.
“FDA intends to delay enforcement of the above provisions to ensure that combination product applicants have sufficient time to update reporting and record-keeping systems and procedures, including their information technology systems, to comply with these requirements,” the agency said. “During the period of delayed enforcement, FDA intends to focus on educating combination product applicants on the above provisions with which they may be less familiar, including providing guidance to help them comply with these provisions. The period of delayed enforcement will provide combination product applicants with additional time to consider the recommendations and technical specifications that FDA intends to provide through the aforementioned guidance as they update their systems and procedures to comply with these provisions.”
All other provisions of the safety data reporting requirements are in effect “because FDA does not believe significant updates to systems and procedures are necessary to comply with these provisions,” the bureau said.