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Mar 131 min read

USFDA Med.Dev: Draft Guidance Select Updates for the Premarket Cybersecurity -Section 524B of the FD&C Act

Today (13 March, 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices and...

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Oct 2, 20231 min read

USFDA MD Guidance: Cybersecurity-Quality System Considerations & Content of Premarket Submissions

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released a final guidance "Cybersecurity in...

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Sep 10, 20232 min read

USFDA Guidance: Premarket Notification [510(k)] Submissions

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health and Center for Biologics Evaluation and Research...

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Jun 17, 20231 min read

USFDA Guidance: Content of Premarket Submissions for Device Software Functions

Last Wednesday (14 June 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health, Center for...

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Sep 28, 20222 min read

USFDA Guidance: Six Finalized Medical Devices Guidelines

USFDA finalized and released Multiple Medical Devices Guideline earlier today (28 September 2022). 1. Guidance on: Clinical Performance...

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Sep 23, 20221 min read

USFDA Guidance: Electronic Submission Template for Medical Device 510(k) Submissions

This document was issued on September 22, 2022. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be...

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Jun 18, 20221 min read

USFDA Guidance on Technical Performance Assessment of Quantitative Imaging in Radiological Device

According to the guidance document, FDA recommends what information should be included in a premarket submission for radiological devices...

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Apr 10, 20221 min read

FDA's Draft Guidance on Cybersecurity in MD: Quality System Consideration & Content of Premarket Sub

This draft guidance document is being distributed for comment purposes only. Cybersecurity incidents have rendered medical devices and...

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