Newsletter - September 22, 2022
FDA will Accept 510k Submissions Only Electronically
Starting next year, FDA would stop accepting 510k applications as paper submissions or even as an eCopy loaded on to a DVD or a flash drive. The only acceptable format for submission of an electronic 510k applications would be those created using the eSTAR template released earlier this year. While electronic submission of...Read More
Is the Pandemic Over?
This week, President Biden’s statement that the “pandemic is over” created a media storm. Public health experts were split on if the statement was premature or if it is time to move on from the classical definition of the pandemic. From a regulatory point of view, the statement from the President could indicate a significant...Read More
FDA will Accept 510k Submissions Only Electronically
Starting next year, FDA would stop accepting 510k applications as paper submissions or even as an eCopy loaded on to a DVD or a flash drive. The only acceptable format for submission of an electronic 510k applications would be those created using the eSTAR template released earlier this year. While electronic submission of...Read More
Is the Pandemic Over?
This week, President Biden’s statement that the “pandemic is over” created a media storm. Public health experts were split on if the statement was premature or if it is time to move on from the classical definition of the pandemic. From a regulatory point of view, the statement from the President could indicate a significant...Read More
