FDA Final Guidance Requiring Electronic Submissions

Electronic submissions to the FDA will soon no longer be optional – this new guidance requires e-submission for many types of submissions. The FDA final guidance document, Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act, was issued on July 15, 2020.
Under this guidance, electronic submission will be required for:
  • 510(k)
  • De Novo
  • PMA
  • PDP
  • IDE
  • HDE
  • EUA
  • Pre-submissions
Additionally, all follow-on submissions to these listed submissions, like supplements and reports, must also be in electronic format. Although the FDA has not yet disclosed how a potential waiver process will work, they have listed some exemptions to the e-submission requirement. Expanded access compassionate use requests, emergency use reports, and adverse event reports will not be required to follow the electronic submission guidance.
The individual draft guidance documents for the various types of submissions will be released sequentially. They will address the electronic format, subject matter, and scope for each type of submission.  FDA said that, “Once an individual guidance is finalized and published on FDA’s Web site, and the timetable for implementation described in that guidance has passed, the guidance will be considered to have binding effect.” This means that the start date for the required electronic format is still unknown – and it will likely be different for each specific submission, as the individual submission guidances will be released sequentially.
Be sure to check our website regularly to be notified when the individual e-submission guidances are released.
See all of our FDA-related posts here: https://www.softwarecpr.com/tag/fda/
About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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