By Stewart Eisenhart, Emergo Group Canadian healthcare market regulator Health Canada is developing new requirements for certain hospitals to report serious medical device incidents and adverse drug reactions to better protect public health. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
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FDA user fee reauthorization advances without $1B fee increase
By Stewart Eisenhart, Emergo Group The US Senate’s version of a bill reauthorizing Food and Drug Administration user fees over the next several years diverges markedly from President Trump’s budget proposal to increase user fees by $1 billion in 2018 alone. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]
FDA guidance explains electronic records for medical device clinical trials
By Stewart Eisenhart, Emergo Group US Food and Drug Administration medical device regulators have published new draft guidance recommending proper use of electronic records and signatures in clinical investigations. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect […]
FDA commissioner proposes new program for digital health product regulations
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration plans to roll out a new program for mobile medical apps and related digital health products in order to clarify the agency’s regulatory scope regarding these technologies. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
Brazilian medical device regulators change registration submission formats
By Stewart Eisenhart, Emergo Group Brazilian medical device regulator ANVISA has adjusted its electronic submission policy for marketing authorization applications, now accepting both electronic and paper formats of documents. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect […]
FDA Science: Working at the speed of emerging technologies
By Luciana Borio, M.D. Let’s face it, we’ve all gotten used to nearly instant access to almost anything. Today, with a tap of an app, we order a car ride, a book, or pizza for dinner. Need to navigate past traffic in downtown city streets? No problem. There’s an app for that, too. Some may […]
Fostering medical innovation: A plan for digital health devices
By: Scott Gottlieb, M.D. It is incumbent upon FDA to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable the efficient development of these technologies. By taking an efficient, risk-based approach to our regulation, FDA can promote […]
Peruvian regulators push for faster medical device approval timeframes
By Stewart Eisenhart, Emergo Group The Peruvian government has rolled out a raft of updates to the country’s medical device regulatory system, including an initiative to reduce approval timeframes for all device classes. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
FDA expands 510(k) validation data requirements for reusable devices
By Stewart Eisenhart, Emergo Group Medical device market regulators at the Food and Drug Administration have issued a new list of reusable medical devices for which validated Instructions for Use as well as validation data for cleaning and sterilization will be required for 510(k) submissions. Get the full story here at the Emergo Group’s blog. […]
How creative FDA regulation led to first-in-the-world approval of a cutting-edge heart valve
By: Jeffrey Shuren, M.D., J.D., and Bram Zuckerman, M.D. Nearly six years ago FDA approved an artificial transcatheter heart valve (THV) to treat patients having severe symptoms and life-threatening heart problems such as fainting, chest pain, heart failure, irregular heart rhythms, or cardiac arrest, because one of the valves in their heart (the aortic valve) […]
