October 21, 2014. NCHR strongly supports inclusion of separate analysis of safety and effectiveness for demographic subgroups in clinical trials for drugs and devices. It is essential that methodologically sound data about how drugs and devices work in these groups be conducted and made publicly available.
Read More »On Health Policy
NCHR Comments on De Novo Classification Process
October 14, 2014. As members of the Patient, Consumer, and Public Health Coalition, we have serious reservations about the use of the de novo classification process for implants, life-sustaining, and life-saving devices. We believe that all such high-risk devices should be Class III devices reviewed through the more rigorous PMA process.
Read More »NCHR Comments on Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications
October 14, 2014. We oppose the draft guidance as written and strongly urge the FDA to rewrite it. The current draft guidance relies on vague wording and subjective judgments, not science or technological assessments. When it is more specific, it promotes the use of surrogate endpoints and the risk tolerance of a small number of patients whose views come to the FDA’s attention.
Read More »NCHR Testimony at FDA Advisory Panel on Device Classification
Oct. 9, 2014. NCHR supports the FDA’s recommendation that More-than-Minimally Manipulated (MMM) Allograft Heart Valves be classified as Class 3 devices and therefore subject to the premarket approval process. All other types of heart valves under the oversight of the Center for Devices and Radiological Health at the FDA are classified as class 3. There is no reason that these heart valves should be an exception.
Read More »Comments on Intent to Exempt Certain Medical Devices From Premarket Notification Requirements
October 6, 2014. We strongly urge the FDA to reassess the Submission Type for the above devices and continue to require 510(K) clearance due to the high number of MAUDE reports, including numerous deaths from these devices. Devices that can cause fatal adverse events should not be exempt from FDA regulation.
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