Sen. Chuck Grassley, Chairman of the Committee on Finance, issued the followingcomment about a report to be released on Monday, July 18, at 4 p.m. by the Institute of Medicine.
Sen. Grassley’s comment is
“This report exposes a fissure in the FDA’s safety mission when it comes to surveillanceof medical devices for children. It documents how the FDA is neither properly monitoringpostmarket studies nor making important postmarket research publicly available. These are thesame kinds of problems we’ve seen with postmarket review of medicines. The Institute ofMedicine spells out remedies that should be pursued to better protect children who rely on FDAapprovedmedical devices, and I intend to work to help improve the situation."
Source: Ranking Member’s News