The FDA Sept. 25 released draft guidance outlining how it will move toward requiring that regulatory submissions to the agency for medical devices be provided in electronic format.

The FDA Reauthorization Act of 2017 (FDARA), enacted in August 2017, requires that a variety of submissions for devices — including premarket approval (PMA) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications, and de novo classification requests — be submitted electronically. The requirement applies as well to supplements to those documents and any appeals of those submissions. The electronic format mandates are to go into effect on dates specified by the agency in final guidance (21 U.S.C. §379k-1(b)(3)).

FDARA also required the FDA to issue draft guidance by Oct. 1 that would provide standards for electronic format submissions, a timetable for establishing the standards, and criteria for waiver of and exemptions from the electronic submission requirements.

Also, in the commitment letter negotiated by the FDA and stakeholders in the run-up to enactment of the Medical Device User Fee Amendments of 2017 (MDUFA IV), Title II of FDARA, the agency committed to developing “electronic submission templates that will serve as guided submission preparation tools for industry.” The templates were to be designed “to improve submission consistency and enhance efficiency in the review process.” The commitment letter called for the FDA to issue draft guidance by Oct. 1 on the use of the electronic submission templates.

Individual Formats Still in the Works

In the new draft guidance document, which was intended to satisfy the electronic submission draft guidance mandates in FDARA and the MDUFA IV commitment letter, the FDA said that it had concluded that it was “not feasible to describe and implement the electronic format(s) that would apply to all the submissions covered by [the FDARA requirements] in one guidance document.”

Given this conclusion, the agency said, the new draft guidance “describes how FDA interprets and plans to implement the [FDARA requirements], while individual guidances will be developed to specify the formats for specific submissions and corresponding timetables for implementation.”

As outlined in a Federal Register notice of the draft guidance document’s availability, published Sept. 26 (84 Fed. Reg. 50850), the guidance covers the submission types that must be submitted electronically, criteria for waivers of and exemptions from the electronic format submission requirements, and the timetable and process for implementing the requirements. The document also covers additional submission types for which submission in electronic format is not required but will be recommended.

Submissions Requiring Electronic Format

According to the draft guidance, the requirement that PMA submissions be in electronic format extends to all PMA types, including original PMAs, panel track supplements, 180-day supplements, manufacturing site change supplements, 30-day notices, 135-day supplements, and post-approval study supplements and reports. Also included in the mandate are amendments involving correspondent and ownership changes and requests for extensions, as well as transitional and modular PMAs.

In addition to PMAs, 510(k)s, IDE applications and de novo requests, electronic formatting will be required for the following device submissions:

• product development protocols (PDPs);
• humanitarian device exemption (HDE) applications;
• emergency use authorizations;
• investigational new drug applications (INDs) required before submission of biologics license applications (BLAs) for devices regulated by the FDA Center for Biologics Evaluation and Research (CBER) as biological products;
• BLAs for devices regulated by CBER as biological products; and
• submissions subsequent to an original submission, including amendments, supplements and reports.

The FDA also recommends that Q-submissions for devices other than pre-submissions be made in an electronic format, even though such formatting is not required. The electronic format requirements also will not apply to medical device reports (MDRs) submitted under 21 C.F.R. Part 803.

The FDA may also recommend electronic formats for master access files, 513(g) requests for information, and CLIA categorization requests and waiver applications.

Two types of IDE submissions — compassionate use requests and adverse event reports — will be exempt from the electronic format requirements. More exemptions will be discussed in the individual guidance documents covering specific submission types.

Rollout Process

According to the draft guidance, the FDA will develop individual draft guidance documents to specify the electronic formats, subject matter and scope of applicability for specific submission types. The availability of the individual draft guidance documents will be announced through Federal Register notices, and comment periods for each draft guidance will be specified in the notice.

Final electronic format guidance documents will be posted on the FDA’s website. The final guidance documents will specify the dates on which the various electronic submission mandates will go into effect.

Comments on the draft guidance must be submitted by Nov. 25 and may be submitted online (Docket No. FDA-2019-D-3769).