What Can Medtech Expect with the New Congress?

Given the drop in warning letters over the past few years and the expansion of the Medical Device Single Audit Program, it appears that FDA has been implementing a policy of “voluntary” compliance. However, FDA policy is basically controlled by Congress, so as result of the November 6 national election results, the medtech industry should expect a major shift. The country has voted out the industry-leaning Republicans, and the consumer-protecting Democrats have been given control. Consequently, the industry could expect new policy from FDA. The present lack of regulatory actions and warnings could be replaced with a more diligent approach to 483s and warning letters. Past history with such a change in oversight from the Republicans to the Democrats has shown that the number of warning letters issued could return to higher numbers.. The medtech industry should be prepared to deal with the new Congress, which takes control in January. It may take a while for a shift in regulatory policies to occur, but a change is in the air. Warning Letters FDA has issued a total of 24 warning letters to the medical device industry during fiscal year 2018. That is two warning letters per month. From the chart below, you will see that the number of warning letters issued to the industry has been falling from its high point in 2013. Screen Shot 2018-12-04 at 11.45.20 AM.png Above: Number of FDA warning letters per year. Source:Â&nbs...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news