FDA Reform Could Pose a Danger to 510(k) Process

In a Q&A with the Star Tribune, Mark DuVal, president of DuVal & Associates P.A. (Minneapolis), suggests that reform at FDA will hurt the medical device industry. His main concern was the 510(k) process, a program that has been criticized for flaws and is being reviewed by the Institute of Medicine.

December 7, 2009

1 Min Read
FDA Reform Could Pose a Danger to 510(k) Process

DuVal says that the 510(k) process works well, because it gives FDA the flexibility to request more information about products from companies while keeping innovation alive. Without the program (or if the program significantly changes), venture funds will "dry up" and the strength of the U.S. medical device industry will be destroyed.The Star Tribune also asked DuVal what the industry thought of Margaret Hamburg's appointment to FDA commissioner, to which he responded, "Everybody is kind of wondering why she was chosen. Nobody completely understood her qualifications for heading up FDA."UPDATE: On December 12, the Star Tribune published an editorial stating that Jeff Shuren, acting director of CDRH, has said that no big changes to the 510(k) process are on the horizon.

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