The power and promise of artificial intelligence comes in a Pandora’s box full of novel and multi-dimensional enterprise risks—legal, regulatory, financial, operational, ethical and reputational—that go above and beyond those associated with other technology innovations.
From a new FDA commissioner to 510(k) review times, here's what to expect in the way of medical device industry changes this year.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Should you ever have an FDA inspection, you’re going to want to know what to do after. And if you’re a medical device company with class II or class III products registered with FDA, you need to be prepared for an FDA inspection. Technically, FDA is mandated to inspect any company with class II or […]
Filing 510(k)s isn't always an easy process. Here are some tips to avoid setbacks.
Over the past several years, FDA has been more aggressive and active in performing medical device company inspections. This has lead to a far greater number of companies receiving form 483 warning letters and citations. 483’s are a good way for your medical device company to flush $400,000 down the drain. Has it been a […]
Is it a matter of Freedom of Speech to allow pharma companies to discuss off-label use of its drugs? A recent New York lawsuit just tested this idea out.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
New FDA guidance is meant to exempt certain unclassified, Class I and Class II devices from premarket notification requirements.
The number of FDA drug recalls is swelling year after year, but 2014 is on track to having the all-time record for medications removed from the market. The why’s of this are still conjecture – perhaps it’s linked to the fungal meningitis outbreak of 2012 – but the trend is pretty glaring… …Or so says Alexander Gaffney at the […]