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FDA Announces Online Electronic 510(k) Submissions

by Devices and Pharma | Dec 18, 2022 | Med-Devices, Reg_Information, US-FDA

The U.S. Food and Drug Administration (FDA) announced the issuance of its final guidance document for its template for electronic 510(k) submissions on September 22, 2022. The electronic Submission Template and Resource (eSTAR) electronic submissions template is a...
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