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.
Legislators in the US House of Representatives and Senate are considering bills that would exempt several types of software, mobile medical devices and apps from Food and Drug Administration (FDA) oversight.
The Colorado State University Spring Semester session will be starting in May 2014 regarding FDA 21 CFR 820 in the College of Biomedical Engineering. The title of the class is “FDA Quality System Regulation (21 CFR 820) and ISO 13485:2003 for Medical Devices” [EGLL 4094]. Lori Carr helped develop the material that will be presented during this ten (10) week session. Lori has taught this class during the Spring semesters of 2011, 2012, and 2013. She will assist with the 2014 session as her schedule permits. Please check the CSU website for specific information regarding this class or contact Deanna Scott at 970.402.5330 or e-mail her at [email protected] for more information.
Japan’s Ministry of Health, Labour and Welfare (MHLW) has set a late November 2014 date to begin enforcing revised regulations for medical devices and pharmaceutical products.