Labeling and photographs in a 510(k) database?

The FDA is considering to start a publicly accessible database that will contain labeling (user manuals!) and pictures of 510(k) cleared devices. FDA is organizing a "discussion meeting" on April 7th in their offices in MD. Attendance is free after registration. What is your position on this issue? Let me know!

In development: stretchable electronics

First time I heard about this: NW University and UofI (both in IL) are developing "stretchable" electronics to be used in catheters. See this interesting article about an application for minimally invasive heart surgery. Before you know it, this technology will invade everyday products and gadgets!

Medical device development: an endangered species?

An article in the StarTribune (Minneapolis-St. Paul) argues that big device companies are spending too much time adding features to existing product lines and too little time developing new technologies. Add to that the unfavorable investment climate for startup companies, and a bleak future for new products emerges.

Yes, the FDA's failures have been all over the news

But still, I think it is important to post this article about the impact on the US Medical Device industry.

The US is losing its competitive edge...

An article in the Startribune, Minneapolis, explains a study by PricewatterhouseCoopers, predicting that in the coming decade the US will lose its competitive edge in medical devices to countries such as China, India and Brazil. Why? We don't invest in our future!

510(k) viewed from Italy

From Italy comes to us Dr. Maria Donawa, who discusses The Evolving US 510(k) Review Process in a well-wrought, interesting article. The FDA's struggles are followed not only here in the US, but all over the world! I'm just crossing my fingers that the FDA won't succumb to the "runaway bureaucracy" syndrome that is so infectious in government circles. Alas, I'm not optimistic...

FDA's registration and listing: opaque and impossible

I consider myself an "old hand" at registering medical device companies, but I still manage to get myself in trouble. As you probably know, registration must be done on the FDA's website. Recently I tried to register a US subsidiary of a foreign company, and I could not find a way to enter the foreign company's information! Worse, there used to be (albeit in a difficult-to-find place) an email address where one could contact the FDA and get help, but I could not find that anymore! So much for a "customer friendly" and "transparent" FDA.