The US Food and Drug Administration (FDA) issued a proposed rule Wednesday that marks the official first step in shifting away from the current voluntary approach on device submissions in electronic format.
The proposal aims to improve the efficiency of the device premarket submission program by requiring a single submission in electronic format.
FDA intends for the move to reduce unnecessary regulatory burden on industry. The rulemaking affects 510(k) submissions, investigational device exemption applications, premarket approval applications and humanitarian device exemption applications reviewed at FDA’s Center for Devices and Radiological Health (CDRH) or its Center for Biologics Evaluation and Research.
In a broader sense, the proposed rule speaks to harnessing the potential associated with the reproducibility and availability of data in electronic submissions (eSubmissions). This is aligned with ongoing work in collaboration with the International Medical Device Regulators Forum.
“FDA has been moving toward transforming all regulatory submissions from mailed copies to electronic means via the internet,” the agency said. The FDA Reauthorization Act of 2017 added fuel to the fire with provisions that called for all submissions to be in electronic format only…