The FDA guideline “Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act” on electronic submission for Medical Devices was published on July 15, 2020.

The FDA document defines which submissions can be made electronically and the criteria for possible exemptions under Section 745A(b) of the Federal Food, Drug and Cosmetic Act.

FDA guideline on electronic format sending for Medical Devices
FDA guideline on electronic format sending for Medical Devices

FDA guideline: what are electronic mailings?

Section III.A of the new FDA guidance clarifies what mailings can be submitted in electronic format:

  • Pre-market notifications [510(k)].
  • Evaluation of Automatic Designation Application (De Novo) [513(f) (2)].
  • Pre-market approval (PMA).
  • Product development protocols.
  • Requests for exemption for clinical investigation devices.
  • Requests for exemption for humanitarian devices.
  • Emergency Use Authorizations (EUA).
  • Some investigational applications for new drugs (IND).
  • Biological License Applications (BLA).

When will electronic submission be mandatory?

At the moment, no definite date has been set. However, in the meantime, the FDA is working on developing individual guidelines to specify the electronic format and scope of applicability of these submissions. These guidance documents will be published sequentially on the FDA website.

Once the guidance draft has been reviewed, the final guideline on electronic submissions will be ready and published on the FDA website.

Would you like more information?

Thema offers strategic-regulatory consulting services to manufacturers and distributors of Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD) on national and international markets.

Thema’s objective is to provide support to Customers in achieving their business goals thanks to a reliable and competent partnership in the regulatory field.

Thanks to a network of partner agencies, Thema provides a series of services to offer the right support in the registration of Medical Devices and in vitro diagnostic Medical Devices with foreign Regulatory Authorities.