Hogan Lovells Publications | Medical Device Alert | 26 September 2019
FDA issues draft guidance on providing regulatory submissions in electronic format
On 26 September 2019 the U.S. Food and Drug Administration (FDA or the agency) published a draft guidance document entitled "Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act," which is available for public comment.
FDA issued the draft guidance in compliance with the statutory mandate to provide draft guidance before 1 October 2019, but limited the scope of this document to describing how FDA interprets and plans to implement the requirements of section 745A(b)(3) of the Federal Food, Drug, and Cosmetic Act (FDC Act). In short, the draft provides a general statement of the agency's intent to establish standards for electronic format submissions and issue individual final guidances covering the electronic format and timetables for each specific submission type. Under the authority granted by legislation, the final guidances will be binding with respect to standards for submission, timetables, and criteria for waivers and exemptions.
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