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.
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.
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 The proposed label also would replace out-of-date serving sizes to better align with how much people really eat, and it would feature a fresh design to highlight key parts of the label such as calories and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.
U.S. device makers laud India’s new Medtech proposal; New laws proposed by India healthcare regulators would for the first time treat medical devices as a category distinct from pharmaceuticals.
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.
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.
For the third time ever, the US Food and Drug Administration (FDA) has approved a new diagnostic test under “emergency use” provisions granted to it in 2013 under a little-known law.
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.
In a major shift, the US Food and Drug Administration (FDA) today announced that it is looking to study the potential impacts of an alternate format for direct-to-consumer (DTC) television advertising, one in which companies would only be required to list the major—not all—risks associated with the use of a drug.
Association says survey points to 14,000 job cuts and 19,000 delayed hirings, but others say 38-firm sample is too small.