Device Firms to Prep for Electronic Submission Shift Under FDA Proposed Rule

Regulatory NewsRegulatory News
| 12 September 2018 | By Ana Mulero 

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.
The shift is based on FDA guidance, issued in 2013 and last updated in 2015, that marked the beginning of the eCopy program for device submissions. The guidance provides instructions for processing eCopies and technical standards based on FDA’s experience with the program. It also lists the number of copies for each submission type that would be required or voluntary.
Device sponsors have had the option of using FDA’s eSubmitter software for transmissions on the Electronic Submission Gateway since January 1999, according to the proposed rule. This software is undergoing fundamental changes for digitization of global harmonization efforts.
These eSubmissions, however, differ from eCopies as sponsors are required to mail eCopies to the agency. “FDA considers eCopies, submissions copied to a CD, DVD, or flash drive and mailed to FDA, and eSubmissions to be submissions in electronic format,” the agency clarified.
Yet the proposed rule also introduces FDA’s plans to replace mailing addresses with a new website for these to be listed and updated online. This would eliminate the need for FDA to set forth amendments to current regulations every time these addresses needed to be updated.
Other efforts currently underway that are intended to modernize the premarket submission program include the Quality in 510(k) Review pilot program, launched last week, the 2014 eSubmissions pilot program for 510(k)s and the expansion of the Abbreviated 510(k) program


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