Search
USFDA Med.Dev: Draft Guidance Select Updates for the Premarket Cybersecurity -Section 524B of the FD&C Act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...
Sharan Murugan
Mar 13, 20241 min read
19 views
0 comments
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...
Sharan Murugan
Oct 2, 20231 min read
7 views
0 comments
![USFDA Guidance: Premarket Notification [510(k)] Submissions](https://static.wixstatic.com/media/nsplsh_453363554d4e4263424363~mv2.jpg/v1/fill/w_1596,h_1200,fp_0.50_0.50,q_90,enc_auto/nsplsh_453363554d4e4263424363~mv2.jpg)
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...
Sharan Murugan
Sep 10, 20232 min read
24 views
0 comments
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...
Sharan Murugan
Jun 17, 20231 min read
22 views
0 comments
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...
Sharan Murugan
Sep 28, 20222 min read
9 views
0 comments
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...
Sharan Murugan
Sep 23, 20221 min read
34 views
0 comments
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...
Sharan Murugan
Jun 18, 20221 min read
20 views
1 comment
FDA's Draft Guidance on Cybersecurity in MD: Quality System Consideration & Content of Premarket Sub
This draft guidance document is being distributed for comment purposes only.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...
Sharan Murugan
Apr 10, 20221 min read
13 views
0 comments