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 […]
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 […]
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 […]
