How dense can one get?

The FDA is warning that scammers impersonate FDA "special agents", see their web entry. Apparently people who have bought drugs over the Internet are threatened and told to wire a "fine" to some offshore bank account. I hope none of my blog readers fall for that! Remember, no matter what, only an US Judge can impose fines, payable to the US Treasury!

FDA opens office in Mexico City

The FDA has opened an office in Mexico City to help enforce its regulations for food- and medical device safety. "FDA experts in Mexico City will work closely with local industries that ship food and medical products to the United States to improve their understanding of U.S. safety and product quality expectations", said Murray M. Lumpkin, M.D., U.S. FDA Deputy Commissioner for International Programs. See the Press Release.

Changes to the 510(k) process

In light of recent developments, such as allegations of improper 510(k) clearances instigated by FDA officials, and the removal of Dr. Schultz as head of CDRH, many people expected the FDA to change the 510(k) process drastically. But this may be further off than you think, according to Dr. Jeffrey Shuren acting CDRH director, in an article in the Startribune.

FDA watches your website!

Recent warning letters declared products "adulterated" (that's not good!) because of unauthorized claims on the manufacturer's website. In particular, you are not allowed to advertise your product for uses that are not covered by the 510(k) clearance or the PMA. For instance, an powered muscle stimulator that was cleared for pain management and massaging may not be advertised for muscle toning or something similar, even though you could possibly get 510(k) clearance for that intended use also. Forewarned is forearmed: be very careful not to go overboard with your website claims because the FDA is watching!

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.