I have been interested in how to fix it for a long time. In fact, when I was the chairman of the subcommittee, we held a hearing in 2009. Quite frankly, both before and after that hearing, I was of the opinion that the 510(k) process was broken, so I am glad that FDA has focused its attention on resources and how to improve it.
Pallone expresses his long-standing concern about the 510(k) process and supports FDA's improvement efforts.
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