FDA recently reported a startling fact: Most of the pediatric medical devices approved in fiscal 2017 were originally intended for adults. Health providers, especially in NICUs, are continually altering devices in order to do all they can to save infants and children, but the situation is not ideal, Michael Drues, a regulatory consultant based in […]
Vascular Sciences
Artificial intelligence and medical devices: Why you need to care
Artificial intelligence presents a whole host of regulatory challenges when it comes to medical devices. Regulatory consultant Mike Drues says he has had clients forced to dumb down their AI technology, with U.S. FDA requiring they lock the algorithm. Drues sees locking the machine learning algorithm is a Band-Aid solution — not a longterm fix. […]
How is the partial government shutdown affecting FDA?
The FDA is not accepting new medical device registration applications funded by user fees during the ongoing partial federal government shutdown. The medtech industry hasn’t been complaining about it yet, but time will tell, according to some experts. Applications for devices covered by the agency’s 510(k) and Premarket Approval (PMA) processes accepted before Dec. 22 […]
Medical device industry regulation is changing: What you need to know
The medical device industry has been taking a lot of heat lately when it comes to patient safety. There’s the recent International Consortium of Investigative Journalists’ “Implant Files” report, as well as the documentary “Bleeding Edge” on Netflix. Both paint a picture of lax medical device regulation resulting in patients exposed to poorly tested implants. Veteran regulatory […]
Is FDA’s easing of medical device malfunctioning reporting a good thing?
The news came out in 2016 that medical device companies were late filing more than 300,000 adverse events reports to U.S. FDA. “I think that’s simply embarrassing as an industry,” regulatory consultant Mike Drues said during his latest podcast with Medical Design & Outsourcing. FDA’s solution has partly been to propose an easing of the reporting requirements. […]
Medical device companies need to worry more about liability: Here’s why
Mike Drues has a piece of advice he likes to repeat to clients of his medical device regulatory consulting business: Don’t fear FDA; fear the product liability attorneys. “You should fear the product liability attorneys because they could impose a heck of a lot more damage on a company than the FDA ever could. And by […]
Biomaterials: Is there a better way for FDA to regulate them?
The medical device industry is pretty conservative when it comes to materials used in medical devices. That begs the question: Do we need a new FDA approval pathway for biomaterials? Mike Drues thinks the answer is “yes.” “It really will encourage companies to use new materials and not be hamstrung with materials that have been […]
Real-world evidence for medtech: what you need to know
Real-world evidence for medical devices has generated a lot of attention in medical device circles since FDA issued guidance about it last summer. The 21st Century Cures Act, passed by Congress in late 2016, actually promotes real-world evidence. The practice offers a way for a medtech company to prove safety and efficacy without necessarily having […]
Off-label use and medical devices: Here’s what you need to know
Promoting off-label use of a medical device – a use not included on a device’s indication with FDA – has become a dangerous practice for medtech insiders, with some facing potential prison time for alleged off-label advertising. But it is still possible to promote off-label use, if you know the rules, says Michael Drues, a […]
Changing your medical device: What you need to know
When it comes to changing a medical device, one of the most important decisions can involve whether to log it in as an internal letter-to-file or submit a special 510(k) or PMA supplement with FDA. In many cases, company officials don’t do some initial investigation before making the decision, according to Vascular Sciences President Michael Drues, who has […]