The US Food and Drug Administration (FDA) has committed to a phased move to electronic submissions of medical device regulatory filings in final guidance now published.
The final guidance, published on 15 July 2020, closely follows the draft version released for consultation in September 2019. One of the main changes is the addition of a section stating FDA will release guidance on different submission types sequentially, thus staggering the transition to electronic filings.
FDA retained the vast majority of the 2019 draft after receiving positive feedback. Medtech trade group AdvaMed proposed just one change, although it did also ask FDA to “provide a reasonable transition time” in its general comments on the draft. This has resulted in a further new section in the final document stating that FDA intends “to consider the time period necessary to transition to use of the electronic format when identifying the date on which electronic format will be required.”