Remote patient monitoring

In the UK remote patient monitoring seems to work - see this article in Medical DeviceLink. Are there any comparable experiences in the US? Let me know, please!

Advertising of medical devices

More and more frequently I see reports about the FDA cracking down on off-label advertising, mostly of drugs but also of devices. These are advertisements that recommend the product for use(s) that are not FDA cleared or approved. And you know what – those ads are illegal! Many times advertising executives do not fully understand the regulations and step over the line. The FDA has, in 2004, published a (draft) guidance for "Consumer-Directed Broadcast Advertising of Restricted Devices". This document makes excellent reading on a rainy afternoon, and it contains recommendations from the FDA about what should be in those ads (and what shouldn't). These recommendations contain elements that are also applicable to written advertisements. Note that ads on your webpage are regarded as "broadcast advertising"!

Stents to treat Erectile Dysfunction

Medtronic is studying the effectiveness of drug-eluting stents for treatment of ED. Read this Medical Device Daily article.

"Fixes" to come to CDRH?

The FDA Commissioner has pledged to fix the CDRH, in particular the 510(k) process. Read all about it: Medical Device Link

FDA and documentation requirements

The article below is from FDAnews; unfortunately the complete article is subscription-only. But the summary is clear enough, I think.


Expert: Document Production Essential Part of Inspections
FDA investigators are cracking down on devicemakers that are not able to produce documents during inspections, Elizabeth Troll, a 25-year veteran of the industry, said at a recent FDAnews webinar. The opportunity to get a second chance to correct observations from inspections is more limited now, she said, because investigators have been clear in their expectations.
The GMP Letter

Want to sell you products in Europe? Changes are on the horizon...

The European MDD that governs CE-marking is getting an update. The Emergo Group has written an newsletter detailing some of those changes and what they may mean to you. Enjoy!

FDA and social media

The FDA is announcing a public hearing to discuss issues related to the promotion of FDA- regulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the Internet and social media tools. Read all about it in the Federal Register. I wonder how that's going to change our lives... more controls?

Medical Device Guru Group

I'm a member of the Medical Device Guru group on LinkedIn, but I never knew that this group has its own website! Check it out if you're interested at http://www.medicaldeviceguru.com

Misconnections between IV's and enteral feeding tubes

A small step by an infusion pump manufacturing might reduce the danger of misconnections. See this Morningstar article.