CDRH finalizes electronic submissions guidance with extended exemption provisions

Working to complete its MDUFA IV commitments, the FDA has finalized guidance on using an electronic submission template system for 510(k) submissions with an implementation date of October 2023. Following some concerns from industry about the technical limits of the template system, the final guidance adds exemptions from using the electronic templates, but maintains that the agency does not intend to issue waivers.

Background: Electronic submissions for medical devices

Under section 745A(b) of the Federal Food, Drug and Cosmetic Act, as amended by the FDA Safety and Innovation Act (FDASIA), the FDA has the statutory authority to require medical device submissions – including amendments or supplements – to be submitted under specific electronic design formats.

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