Comments on Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices

Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 August 25, 2014 Comments of Members of the Patient, Consumer, and Public Health Coalition on the Draft Guidance Medical Device Data Systems, Medical … Continue reading

Comments on Distributing Risk Information for Approved Prescription Drugs and Biological Products

Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 (HFA-305) Rockville, Maryland 20852 August 25, 2014 Comments of the Patient, Consumer and Public Health Coalition on the Draft Guidance for Industry on “Distributing Scientific and Medical … Continue reading

Testimony Before the Cardiovascular and Renal Drugs Advisory Committee on NDA nebivolol/valsartan fixed-dose combination tablets for treating hypertension

Written by Laurén A. Doamekpor September 9, 2014 Good afternoon. My name is Anna Mazzucco and I’m speaking on behalf of the National Center for Health Research. Our non-profit research center assesses scientific and medical data and provides objective health information to … Continue reading

Comments on the Up-Classification of Flu Detection Tests

Members of the Patient, Consumer, and Public Health Coalition strongly support the up-classification of influenza detection devices. We support moving the devices from class I to class II with special controls and into a new device classification regulation (from 21 CFR 866.3330 to 21 CFR 866.3328). We agree with the FDA that “the accuracy of these devices has serious public health implications,” since influenza can cause serious illness and death. Continue reading

Comments on Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices

Members of the Patient, Consumer, and Public Health Coalition appreciate the opportunity to comment on the draft guidance for the Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices. The draft guidance states that the use of consensus standards will “streamline premarket review” and “facilitate market entry for safe and effective medical products.” We support a more efficient process, but are concerned about the potential for lowering the standards for safety and effectiveness since the draft guidance states that one of the purposes of declaring conformance with a consensus standard is to “reduce the amount of supporting data and information that are submitted to FDA.” Continue reading

Comments on proposed rule to allow FDA to regulate all tobacco products

As members of the Patient, Consumer, and Public Health Coalition we are writing to comment on various aspects of the proposed rule to extend FDA’s jurisdiction to tobacco (including made or derived from tobacco) products other than cigarettes, including e-cigarettes. It is essential that the proposed rule be strengthened, since nicotine is highly addictive. Continue reading