February 12, 2020
The countdown is on for medical device manufacturers to prepare for the EU Regulation on Medical Devices (MDR), which will fully apply in member states from May this year.
But in a recently published paper, trade association MedTech Europe raised concerns that the new regulatory system is not ready to support the transition of technology from the old regime.
The new EU MDR came into force on May...
December 6, 2019
Digital health has gone global. On both sides of the Atlantic, healthcare stakeholders are evaluating these new tools, while innovators are navigating the pathways to implementation. It’s clear that while the North American markets and the European markets each have their own challenges, the industries also share plenty of universal opportunities and obstacles.
This week at the European...
September 10, 2015
by Bradley Merrill Thompson
Let’s say no one had ever invented the tongue depressor, but this year, in a flash of inspiration, I came up with the idea. Indeed, let’s say there’s nothing else like it. To bring the first tongue depressor to market, it’s quite likely I would have to spend years conducting clinical trials, to be followed up by perhaps a year of FDA review. For a tongue depressor. Why...
January 16, 2015
As promised in its FDASIA report, the FDA has published a draft guidance document that aims to help those creating wellness devices and apps to better understand when their product (or their marketing claims) crosses over into regulated medical device territory. As always the agency is seeking comment from the industry and the public on their new draft guidance for the next 90 days.
November 25, 2013
In a public letter dated November 22, the Food and Drug Administration has instructed personal genome startup 23andMe to immediately stop selling its testing service until the offering receives de novo 510(k) clearance. Regulatory Focus first spotted the letter.
"[M]onths after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not...
July 5, 2010
Wireless-enabled implantable devices enable care providers to check-in on a pacemaker's battery levels or how well an infusion pump is functioning, which means care providers can take action to prevent and harm to the patient. Of course that connectivity -- that feedback loop -- could also be used by hackers as a way to hurt people. "Could be" but, according to the Boston Globe, there's never...
April 19, 2010
By Bradley Merrill Thompson
(I would like to thank Tim Gee of Medical Connectivity Consulting and Mike Robkin for their comments on a draft. The views expressed, right or wrong, are only the author’s and should not be attributed to anyone else.)
At mHealth meetings, I keep hearing representatives from hospitals and other healthcare caregivers say they don’t believe FDA regulations extend to...