FDA Partners With Health Canada On E-Submission Pilot
The pilot will allow manufacturers to use the same digital application format for regulatory consideration by both agencies.
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The guidance document explains the history of and requirements for electronic submissions of 510(k)s.
This feature compiles news briefs on a range of US regulatory and legal happenings. This week: Medtronic seeks HeartWare batteries; companies sign health equity pledge; insulin dosing app cleared; recall on field decontamination kits; and the renewal of an FDA panel.
A recent webinar ranking last year’s best and worst legal verdicts said that product liability cases involving pelvic mesh and artificial lenses were the very worst.