New FDA Approval Path for Medical Devices

There’s been a lot of interest in what the FDA is going to do as far as regulation of various medical devices. For example, they recently approved the first iPhone app for Radiology. The question is how far will they go. I don’t think the major concern by medical device manufacturers is really about the FDA having to give approval for their device. I think the major concern is the time it takes the FDA to do so.

The FDA recently announced a new pathway to FDA approval for breakthrough medical devices. Here’s a short description of it from Med Page Today:

The FDA has announced a new initiative to speed “pioneering” medical devices to the market, and its first test will be a novel upper-extremity prosthetic that is controlled by the brain.

The initiative, dubbed the Innovation Pathway, is designed to encourage cutting-edge technologies among medical device manufacturers, according to a press release sent Tuesday morning from the FDA’s Center for Devices and Radiological Health (CDRH).

Of course, this announcement came on the heals of the announcement about 501k fast track approval from the FDA. Here’s some info on that:

Tuesday’s announcement comes as the agency reviews another fast-track approval process, the 510(k) procedure, which was set up to streamline the process of clearing low- to moderate-risk medical devices and in vitro diagnostics for marketing.

Instead of requiring full clinical safety and efficacy data, as is the case for high-risk devices and all drugs, companies can seek faster FDA clearance by documenting that a product is similar to an existing approved device and poses no new safety concerns.

The 510(k) process has come under fire both from industry and from consumer advocates, many healthcare professionals, and some politicians, though on different grounds. Industry has complained that the process is administered inconsistently and with vague standards, such that manufacturers do not know what is likely to be required for a new product.

But well-publicized safety problems associated with some products approved under the 510(k) scheme have prompted criticism that the agency is too cozy with industry and fails to demand adequate clinical data.

The FDA is currently reevaluating the 510(k) process.

While in theory I like that the FDA is keeping an eye out for possible issues with medical devices. I think it’s pretty crazy to think that the FDA might start regulating things like smart phones. I’ve even heard some people say that they could start regulating EMR software. I have a feeling there’s a lot better things the FDA could do with their time than regulating a medical app on my smart phone.