This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
Notably, the FDA can now mandate that confirmatory trials begin before approval, ensuring proactive validation of clinical benefits. The draft also formalizes withdrawal procedures for non-compliance, including delayed studies or failure to confirm benefits.
In manufacturing, an AI-based system assessing drug vial fill levels must be complemented by independent quality control measures to ensure compliance. Non-compliance can arise if training data is not representative or if development lacks transparency.
The FDAs new draft guidance for developers of AI-enabled medical devices marks a critical milestone in addressing the complexities of transparency, bias and safety throughout the lifecycle of these advanced technologies.
We organize all of the trending information in your field so you don't have to. Join 21,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Compliance 
105 
Let's personalize your content