Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

USFDA Med.Dev: Draft Guidance Select Updates for the Premarket Cybersecurity -Section 524B of the FD&C Act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

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...

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...

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...

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...

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...

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...

FDA's Draft Guidance on Cybersecurity in MD: Quality System Consideration & Content of Premarket Sub

This draft guidance document is being distributed for comment purposes only.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...