FDA Proposed Rule Would Simplify Premarket Device Submissions Process

September 14, 2018

The FDA released a proposed rule that would simplify the process for electronic premarket device submissions.

Under the proposal, the agency would require a single submission in electronic format for the device premarket submissions, removing paper and multiple copies from the equation.

If implemented, the proposal would cut the number of copies required in electronic format and streamline the premarket submission program.

It would further amend all device regulations that reference the specific form of a submission to require an electronic submission, thereby generating savings for sponsors without imposing increased regulations, according to the FDA.

The agency also proposes to replace mailing addresses with a website for eSubmissions, eliminating the need for new amendments to current regulations every time the FDA updates addresses.

Read the proposed rule here: www.fdanews.com/09-13-18-Device.pdf. — Zack Budryk