CDRH Director Jeff Shuren told a house panel that the FDA’s workload continues to increase about10 percent every year, in part because of efforts to approve more innovative medical devices and to make better use of real-world evidence in post market surveillance.
The agency still needs all of the money called for by the latest medical devices user fee agreement (MDUFA IV) even if regulations and staffing are cut under the Trump administration, he testified before the House Energy and Commerce Committee.
MDUFA IV would aim to collect $183 million in fiscal 2018, increasing annually to $213 million through fiscal 2022. The fees were previously negotiated by the FDA and regulated industry, to cover medical product reviews through fiscal 2022.
Robert Kieval, founder and chief development officer of CVRx and member of the Medical Device Manufacturers Association’s board of directors, noted that MDUFA IV calls for FDA auditors to cite the specific justification and applicable regulation for any deficiency letter or data request.