FDA Releases Electronic 510(k) Submissions Draft Guidance

The US FDA (Food and Drug Administration) announced that it has released a draft guidance for sponsors using an electronic template for premarket notification 510(k) submissions. According to the drafted guidance, the FDA explained that it plans to accept the electronic Submission Template and Resource (eSTAR) template for the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) applications. The 510(k) Submissions guidance is backed by the 745(A)(b) of the Food and Drug and Cosmetic Act (FD&C Act) which enforces the FDA to start shifting to electronic formats for applications for medical devices.

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