Over the years the job of the FDA has expanded as technology has advanced, to include evaluation of new drugs and devices, including those designed and produced outside the US. The FDA has undoubtedly protected countless people from poisonous and malfunctioning medical products. There have also been stories of egregious failures of the FDA (see this New York Times article of 2009 regarding their inability to police conflicts of interest in biomedical research) which are often attributed to lack of funding and overwork.
In the last few weeks the FDA has caused me, personally, significant grief and frustration. I am shocked and angered, as a citizen, when cortisone products containing mold result in death and disability in hapless patients and when food additives which contribute to a nationwide obesity epidemic go unchecked, but a couple of things hit closer to home than these.
I have been shopping online for the last 8 months for an affordable ultrasound machine that I can use to train myself in some of the more specialized applications of the technology. I can't see spending $40,000 for an American machine, so I have been looking at who in the world produces ultrasound machines for the rest of the world, which also can't afford the super expensive technology. I found the perfect machine, a laptop sized scanner with 4 different transducers, so I can get good at vascular, thyroid, musculoskeletal and intestinal ultrasound, and was able to buy it from the Chinese manufacturer for a bit over $4000. I thought that after learning how well it worked it would be something that I could afford to donate to a project overseas. It was delivered to the shores of the US last week and is probably not going to ever get to me because it is not FDA approved. Ultrasound machines are felt to be of low to minimal risk to humans, so the FDA approval process is not as long as for, say, invasive medical devices, but it is too laborious and expensive for Chinese companies to go through, especially with their lower end models which they can sell just fine everywhere else in the world. I wrote the FDA investigator a letter explaining my plans but I think the chances of getting my machine are pretty poor.