FDA No Longer Notarizing CDRH Export Certificates

The US Food and Drug Administration has stopped notarizing Center for Devices and Radiological Health (CDRH) export certificates including Certificates to Foreign Government (CFG), Certificates of Exportability and Non Clinical Research Use Only Certificates.

US FDA Updates Guidance on Feedback Mechanisms for Medical Device Registrants

US medical device market regulators have updated guidance first issued in 2012 on the FDA’s Pre-Submission feedback program for medical device manufacturers undergoing Investigational Device Exemptions (IDE), Premarket Approval (PMA), 510(k) premarket notification or other premarket reviews.

Chinese Medical Device Revisions Nearing Implementation

The Chinese government’s State Council Executive Committee has approved updates to the country’s medical device regulatory system, bringing the long-awaited revisions closer to actual implementation.

FDA proposes updates to Nutrition Facts label on food packages

The U.S. Food and Drug Administration today proposed to update the Nutrition Facts label for packaged foods to reflect the latest scientific information, including the link between diet and chronic diseases such as obesity and heart disease.  The proposed label also would replace out-of-date serving sizes to better align with how much people really eat, and it would feature a fresh design to highlight key parts of the label such as calories and serving sizes.

Existing 510(k) Guidance to Remain ‘Mostly Unchanged’

In Major Victory for Industry, FDA says Existing 510(k) Guidance to Remain ‘Mostly Unchanged’; The US Food and Drug Administration (FDA) has released the text of a congressionally mandated report outlining its plans for the future of its medical device premarket notification process, also known as the 510(k) clearance process, saying that it intends to largely leave its existing 1997 guidance document as-is.

FDA Finalizes Massive Rewrite of Device Pre-Submission Guidance

 US Food and Drug Administration (FDA) officials in February released an extensive guidance document aimed at clarifying elements of the medical device pre-submission program, now used to provide manufacturers and application sponsors with feedback and advice.

Test ‘predicts’ teen depression risk

A tool for predicting the risk of clinical depression in teenage boys has been developed by researchers. Looking for high levels of the stress hormone cortisol and reports of feeling miserable, lonely, or unloved could find those at greatest risk.