Devices

Electronic Format Regulatory Submission Guidance

FDA has published a draft guidance, Providing Regulatory Submissions for Medical Devices in Electronic Format—Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act, to meet an FDA Reauthorization Act requirement that it issue by 10/1 a draft guidance providing for further standards for the submission by electronic format, a timetable for establishment of the further standards, and criteria for waivers and exemptions from the requirements. The document also is intended to meet a MDUFA 4 commitment involving development of electronic submission templates to serve as guided submission preparation tools for industry.

The agency says it has concluded that it is not feasible to describe and implement the electronic format(s) that would apply to all submissions covered by section 745A(b)(3) in one guidance document. This guidance thus describes how FDA interprets and plans to implement the section’s requirements, while individual guidances will be developed to specify the formats for electronic submissions and corresponding timetables for implementation.

This guidance covers (1) the submission types that must be submitted electronically; (2) the timetable and process for implementing the requirements; and (3) criteria for waivers of and exemptions from the submissions in electronic form requirements.

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