The guidance on Electronic Submission Template for Medical Device 510(k) Submissions states that as of 1 October 2023, FDA will require electronic premarket notification submissions. This date includes a transition period of minimum one year prior to the requirement that all submissions be provided as electronic submissions.
In the guidance you will find:
- further standards for the submission of premarket notification (510(k)) submissions by electronic format,
- a timetable for establishment of these further standards and,
- criteria for waivers of and exemptions from the requirements to meet the statutory requirements.
The requirement that device manufacturers should notify FDA of their intent to market a medical device is stipulated in Section 510(k) of the Food, Drug and Cosmetic Act. The intent must be submitted at least 90 days in advance.
For regulatory assistance on medical devices, including FDA submissions, please contact:
Michelle Christiansen
mich@dhigroup.com
Tel +45 4516 9089
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