FDA Criticizes Submission Quality as User Fee Talks Progress

The FDA is pushing industry to address “chronic quality problems” with 510(k) and PMA submissions to improve review times, as negotiations begin on the Medical Device User Fee and Modernization Act (MDUFMA) reauthorization. The FDA says that some submissions lack basic information, such as descriptions of the device or performance testing data, or fail to give a consistent indication for use. The FDA’s comments come as industry has increasingly complained about the FDA not meeting its performance targets for PMA review and the fact that the number of review cycles a 510(k) device goes through has increased 36 percent since MDUFMA was first authorized in 2002.
Devices & Diagnostics Letter