Al Franken gets involved in the 510(k) process

Al Franken, the senator from MN, is talking with industry and FDA about the proposed changes to the 510(k) process, see The Hill/Healthwatch blog.


The FDA's 510(k) process, used to clear medical devices for sale in the US, is no longer suited to the sheer volume of new ideas and new technologies developed to help the medical community to diagnose and treat diseases. In one word, the process is broken. However, fixing it is extremely difficult: on one hand it should not become so cumbersome that innovative small and startup companies cannot afford to develop new products; on the other hand the process needs to be robust enough to protect the public's health. I am glad that politicians weigh in and hopefully provide viewpoints that may balance the discussions. But I also think that nobody will "get it right" because there is no one right answer that covers all situations adequately.