The FDA has created a new category of devices – general wellness products – that the agency will exempt from regulation. The concept is a boon to makers of apps and other products that help manage weight loss, fitness, stress, sleep, and other aspects of good health.
The China Food and Drug Administration (CFDA; previously SFDA) will launch an expedited registration process on March 1, 2014 to increase availability of innovative and cutting-edge medical devices in the country.
Medical Device Manufacturers often wonder how long it will take for their medical device 510(k) submission to clear. The short answer is: it depends. But that answer doesn’t really satisfy most people. A few years ago the Emergo Group (EG) decided to take a more scientific approach to the issue and started examining FDA data to see how long it really takes a 510(k) to be cleared by the FDA. This year, EG updated their analysis of all medical devices cleared via the 510(k) process between 2006 and the end of 2013.
The FDA’s Center for Devices & Radiological Health aims to improve its clinical trial process, better balance pre- and post-market data gathering and “provide excellent customer service” in 2014.
DA Mulls Faster OK for High-Ned Devices; The FDA wants to create an expedited approval pathway for high-risk medical devices for unmet needs, saying current tools at its fingertips are ineffective for speedier approvals.
The FDA’s powers to reclassify devices were restricted by a federal appeals court ruling that said the agency does not have the inherent authority to reclassify devices. Rather, the FDA must follow Congress’s procedural requirements when reclassifying devices, including notice and comment procedures.
Nightscout touts itself as an open-source, do-it-yourself project to enable remote monitoring of blood glucose levels in patients with Type 1 diabetes.
The iGrow Hair Growth System, a device the company claims to promote male hair growth, won FDA clearance in September 2014 for over-the-counter sales.
In First, FDA Sends Warning Letters to Companies Citing Use of Pinterest: The US Food and Drug Administration’s (FDA) long history of Warning Letters marked a new milestone today after regulators chided three companies, including one which marketed its product on a medium never before cited by FDA: Pinterest.
Primary care doctors may be able to run a blood panel to diagnose depression. Researchers at Northwestern University’s Feinberg School of Medicine have identified 9 RNA blood markers that can be used as part of a panel to diagnose the mental disorder. They said it is the first blood test to diagnose adult depression. They published the results of their study in the Sept. 16 issue of the Nature journalTranslational Psychiatry.