FDA Finalizes Electronic Submissions Guidance
The guidance document explains the history of and requirements for electronic submissions of 510(k)s.
You may also be interested in...
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.
Digital Health Regulations: A Year In Review
RQM’s Allison Komiyama and Kevin Go summarized up the year’s changes to digital health regulation and outlined what to expect in the coming year.
New FDA Guidance Offers Additional Info On eStar Submissions
The US Food and Drug Administration says its guidance for manufacturers seeking premarket clearance is part of the agency’s overall commitment to improve e-submission consistency and enhance the review process.