Monday, November 22, 2010

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.

Monday, November 15, 2010

FDA venturing into medical device design?

What's happening? The FDA announced that they are starting an "External defibrillator improvement initiative" to get industry to improve defibrillators. This is a very interesting development and makes me wonder if we're headed towards government-prescribed "innovation". In my mind this is a slippery slope, and I'd love to hear your comments!