Sep 13, 2018
EMERGO SUMMARY OF KEY POINTS:
Medical device regulators at the US Food and Drug Administration intend to eliminate requirements for paper and multiple copies of premarket applications in favor of single electronic submissions for agency review.
The FDA’s new proposed rule would apply to the following premarket application types:
FDA provides clear information on what the agency considers “electronic format” for premarket submissions. FDA will consider both eCopy submissions provided via CD, DVD or USB and mailed to the agency, and eSubmissions, submitted via the Internet, as qualified electronic submissions.
The proposed rule will go into effect 30 days following publication of its final version in the US Federal Register.
EMERGO SUMMARY OF KEY POINTS:
EMERGO SUMMARY OF KEY POINTS:
EMERGO SUMMARY OF KEY POINTS: