510(k) process should not be hindered

FWe recent saw a short posting on the FDA Law Blog by Jeffery Shapiro and Carmelina Allis, that Minnesota Lawmakers Send Letter to FDA with Concerns About the 510(k) Process. It was posted on Nov. 30th.

Basically it stated that the Minn. Delegation including Democratic Senator Al Franken and Rep. Michele Bachmann, sent a letter to Dr. Hamburg. The letter asked that the “FDA to review the impact of its recommendations to the 510(k) program on patient access as well as the economy, especially the Minnesota’s economy. “ 

The letter made it clear that FDA should ensure that changes to the 510(k) program not stifle innovation or delay patient access to new treatments.

With the changes in the make-up of the Congress after the last election, there is good chance that the policy shift in the FDA oversight committee would take a much different look at the FDA review of the 510(k) process and the changes maybe a lot more subtle.