Day: March 14, 2024

FDA’s previous guidance on cybersecurity aspects of internet connected medical devices provides a detailed description of all the issues that manufacturers must address prior to filing their market approval applications with the FDA. This week the FDA released an update to a few sections of that guidance which would likely require updates to the market … Read more

It is not uncommon for sponsors to use research labs in academic settings for specialized clinical tests not available commercially. However, the convenience of using such labs comes with its own challenges particularly when the sponsor does not follow common sense measures to ensure the quality and reliability of the tests conducted at these labs, … Read more