Regulatory System for Medical Devices Is Weak
Medical Devices,
CQ (2/18, Bristol, Subscription Publication) reported, “While the Food and Drug Administration takes heat from members of Congress over slow approval for medical devices, Public Citizen argues the regulatory system is too weak and that new proposals could endanger patients.
” Public Citizen “objects in particular to bills introduced in Congress that it says ‘aim to ease the approval and clearance processes for medical devices, often by weakening measures intended to ensure patient safety,’ according to a statement from Michael Carome, deputy director and Sidney Wolfe, director, of Public Citizen’s Health Research Group.” These “objections come as Congress works to reauthorize FDA powers to levy user fees to support its drug and medical device approval.
