FDA’s 510(k) Process Under Scrutiny

By Santhosh Nair

Santhosh PhotoIn September of 2009 the FDA commissioned an independent committee review of its 510(k) process, the most common method medical device manufacturers use to bring lower-risk products to market.  In their resultant report, the Institute of Medicine (IOM) recommended a complete overhaul.  Although the FDA has dismissed the recommendations, they are continuing to refine the 510(k) process. This has caused a polarization of the industry experts, those supporting the IOM view and those against it. Those who oppose the current 510(k) process point to the FAA guidelines for more rigor, others point to the FCC guidelines for speed and efficiency, and some advocate for a newer, simpler, better process for lowering the barriers to entry and increasing the number of devices that make it to market. Those who support the 510(k) processes, primarily incumbent medical manufacturers, cite that there is no public health crisis with medical device approval that warrants an overhaul.

In my opinion, we need to evolve the current approval process, but overhauling may not be the right answer, and could tilt the balance in the wrong direction by increasing costs and reducing access.

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