USFDA Guidance: Electronic Submissions for De Novo Requests and Section 513(g) Requests for Information

Yesterday the U.S. Food and Drug Administration (FDA) has released critical guidance documents to streamline the regulatory pathways for medical devices. These documents cover the "Electronic Submission Template for Medical Device De Novo Requests" and the "FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act".

Guidance: Electronic Submission Template for Medical Device De Novo Requests

The FDA's guidance on the "Electronic Submission Template for Medical Device De Novo Requests" is designed to standardize and streamline the submission process. As part of this guidance, standards are provided for the electronic submission of De Novo Requests, a timetable is provided for the establishment of these standards, and criteria are provided for exemptions from and waivers of the requirements to meet statutory requirements.

It is also intended to serve as one of a number of steps in FDA's commitment to developing electronic submission templates that will serve as a guide for industry in preparing electronic submissions to improve submission consistency and efficiency. This guidance describes how FDA will require electronic submissions for De Novo Requests by October 1, 2025.

The submission template includes sections for device description, proposed indications for use, performance data, and other essential information. For, more detailed information on the Electronic Submission Template for Medical Device De Novo Requests, please refer to the official guidance.

Guidance: FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act

Section 513(g) of the Federal Food, Drug, and Cosmetic Act allows manufacturers to request information from the FDA regarding the classification and regulatory requirements for their device.

This guidance outlines a procedure for submitting, reviewing, and responding to requests for information concerning the class in which a device has been classified under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) or the requirements applicable to a device, which are submitted under section 513(g) of the FD&C Act. This guidance was updated to provide information regarding the voluntary submission of 513(g) Requests through the electronic Submission Template And Resource (eSTAR).

Also check out the guidance on "Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide" that is designed to clarify the requirements and help entities meet the high standards of quality necessary for mammography services.