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

Statement of Anna E. Mazzucco, Ph.D. before the 2014 National Antimicrobial Resistance Monitoring System Scientific Meeting

August 13, 2014. We urge the participating agencies to ensure that NARMS receives the funding that it needs to maintain and build upon these vital efforts. Antibiotic resistant infections are estimated to cost the U.S. healthcare system between $21 and $34 billion dollars every year. 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Members of the Patient, Consumer, and Public Health Coalition appreciate the opportunity to comment on the draft guidance for the Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices. The draft guidance states that the use of consensus standards will “streamline premarket review” and “facilitate market entry for safe and effective medical products.”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process, but are concerned about the potential for lowering the standards for safety and effectiveness since the draft guidance states that one of the purposes of declaring conformance with a consensus standard is to “reduce the amount of supporting data and information that are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

Testimony of Dr. Anna E. Mazzucco on Ablatherm high-intensity focused ultrasound device

Prostate cancer is a very common cancer and all the current treatments have serious side effects that harm men’s quality of life. The question today is whether the Ablatherm high-intensity focused ultrasound device is safe and effective for the treatment of low-risk, localized prostate cancer. Most men diagnosed with localized, low-risk prostate cancer will not die from prostate cancer, but from something else. Continue reading

Comments urging FDA to provide higher standards and upclassify surgical mesh for POP and incontinence

On behalf of the National Center for Health Research, I am pleased to have the opportunity to express our views on the proposed order on the reclassification of certain surgical mesh devices and surgical instruments. Our nonprofit Center analyzes and reviews research on a range of treatment issues, and provides objective and understandable information to patients and providers. Continue reading