Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Panel Discusses How New User Fee Law Changes Interactions Between FDA, Industry."
Following is an excerpt:
The new Food and Drug Administration user fees law included a number of meaningful performance goals for the agency that will help change the way it interacts with device manufacturers, a Sept. 20 panel of industry representatives and an FDA official said.
The Medical Device User Fee Amendments of 2012 (MDUFA III) contained in the Food and Drug Administration Safety and Innovation Act (FDASIA) authorized $595 million in user fees over the next five years in return for significant changes in FDA performance and accountability. President Obama signed the law July 9. The law also renews drug user fees and new fees for generic drugs. ?...
Bradley Merrill Thompson, an attorney at Epstein Becker & Green in Washington, during the conference noted that as part of FDASIA, FDA revoked a 2011 draft guidance on when to submit a 510(k) premarket notification for a change to an existing device. ?...
Since guidances are not binding, and only reflect the agency's current thinking about a specific topic, Thompson asked if industry should just ignore the revoked guidance, even if it might have given insight into the agency's updated thinking.
