Medical devices submissions pass to electronic format with FDA

In an effort to improve the effectiveness of the medical device-related pre-market submission program, the FDA today issued the Final Rule, which amends existing pre-market regulations and now requires that submissions only occur in electronic format, eliminating the need for multiple paper copies. Such rule shall enter into force 30 days from its publication (12/16/2019).

At the same time, the FDA has provided the Guidance “eCopy Program for Medical Device Submissions” guide to clarify and guide the regulated industry on the new format of submissions, click here.

Electronic copy (eCopy) is an electronic version of the submission of your medical device created and sent to the Agency on a CD, DVD or flash drive. ECopy must be accompanied of a cover letter in paper. The signature of this letter can be by hand (ie ink) or by means of a valid digital signature.

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Passarini Regulatory Affairs

Published: 12/16/2019

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