FDA Proposes Cutting Device Submission Copies

FDA is proposing to amend requirements for medical device premarket submissions to remove paper and multiple copies and replace them with a requirement for a single electronic format submission. A Federal Register notice to be published 9/13 says the proposal, if finalized, would improve the agency’s premarket submission program for medical devices and create a more efficient submission program. “Because a medical device premarket submission in electronic format is reproducible, and the requirement for multiple copies, whether in electronic format or paper form, is no longer necessary, FDA believes it is beneficial to the public to limit any burden and expense to submitters caused by requiring additional copies,” the notice says.

The regulation update is part of the agency’s response to a 2/24/17 executive order captioned “Enforcing the Regulatory Reform Agenda,” FDA says.