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Life Sciences › Electronic Filing

Hogan Lovells

Medical device 510(k) submissions must be electronic by October 2023, FDA says

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has finalized its guidance “Electronic Submission Template for Medical Device 510(k) Submissions,” which will require medical device 510(k) submissions to use FDA’s electronic...more

Morgan Lewis

FDA Launches eSTAR Pilot Program to Further Simplify Medical Device 510(k) Submissions

Morgan Lewis on

In what appears to be another electronic tool in the US Food and Drug Administration’s quest to move to full digital submissions for medical devices, the eSTAR program provides 510(k) applicants with a PDF template document...more

Hogan Lovells

Pilot program for 510(k) electronic submissions is requesting participants

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) announced that it is soliciting participation in a voluntary pilot program for streamlining electronic submissions for 510(k) premarket notifications for medical devices other than...more

Smart & Biggar

Rx IP Update - May 2017

Smart & Biggar on

Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazodone drug submission - On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that...more

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