On Aug. 12, 2015, The Pew Charitable Trusts submitted comments to the Food and Drug Administration on the reauthorization of the Medical Device User Fee Amendments for fiscal years 2018 through 2022.
The comments outlined opportunities for the agency to strengthen its postmarket surveillance infrastructure, including the establishment of a national system for medical device evaluation, pilot programs to encourage the documentation and transmission of data related to unique device identifiers, and timely completion of post-approval studies.