Comments on Proposed Order “Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs”

September 10, 2013. As members of nonprofit patient, consumer, and public health organizations, we oppose the FDA proposed order that will reclassify stair-climbing wheelchairs (a Class III device, indicating high risk) into Class II (moderate risk). This change in classification would result in greater risk for some of our nation’s most vulnerable consumers.
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Comments of the Patient, Consumer and Public Health Coalition to FDA on “Ensuring Access to Adequate Information on Medical Products for All”

September 9, 2013. Comments of the Patient, Consumer and Public Health Coalition to FDA on “Ensuring Access to Adequate Information on Medical Products for All.” We are writing to express our strong support for the FDA’s efforts to improve how it communicates information on medical products to all Americans, and especially underrepresented subpopulations. Continue reading

Testimony of Brandel France de Bravo, MPH, on Computed Tomography Colonography

September 9, 2013. We agree with the Task Force that at this point, there is no reason to recommend virtual colonoscopies for most patients who need screening. We would add, however, that if specific patients are unwilling to undergo regular colonoscopies, then a virtual colonoscopy is a reasonable alternative. Continue reading

Comments on Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina

August 19, 2013. We are writing as members of the Patient, Consumer, and Public Health Coalition to express our concerns about the proposed down-classification from Class III to Class II of External Counter-Pulsating (ECP) devices for treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization.  We strongly support the proposed PMA for other indications for the same ECP devices. Continue reading

Comments of the Patient, Consumer, and Public Health Coalition on Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning

August 7, 2013 Docket No. FDA-2013-N-0461   As members of the Patient, Consumer, and Public Health Coalition, we urge you to finally follow the recommendations made by FDA classification panels in 1977 and upclassify sunlamp products. All sunlamps should be reclassified … Continue reading

Comments to FDA on “New Approaches to Antibacterial Drug Development”

July 30, 2013. As members of the Patient, Consumer, and Public Health Coalition, we recognize the need for new drugs to reach patients with serious or life-threatening diseases. The pipeline for new antibacterial drugs is shrinking. However, we have grave concerns about proposals to change the standards for meeting FDA’s requirement of two “adequate and well controlled” trials. Continue reading

Comments on Proposed Order “Requests for Ban or Standard on Adult Portable Bed Rails”

Comments of the National Research Center for Women & Families on Proposed Order “Requests for Ban or Standard on Adult Portable Bed Rails”: We are writing to urge the Consumer Product Safety Commission to take strong action to protect consumers from dangerous bed rails by either:
1) Establishing mandatory safety standards for adult portable bed rails with adequate warning labels, OR
2) Banning these bed rails if it is determined that they cannot be made safe. Continue reading

Testimony of Dr Jennifer Yttri, senior fellow, at FDA Advisory Committee on reclassification of blood lancets

Blood lancets, used to test blood sugar levels in diabetics or to obtain blood samples from finger pricks, have been considered a low risk medical device, like band-aids. However, FDA and CDC have found that blood lancets being used on multiple patients have resulted in increasing numbers of hepatitis outbreaks. In a statement to the FDA, NRC made the claim that blood lancets are medium and high risk devices, that require more regulation than low risk devices. Continue reading

Testimony of Dr Jennifer Yttri, senior fellow, at FDA Advisory Committee on sorbent hemoperfusion systems

These systems are used to filter toxins out of the blood . However, there is not proof that the devices save the lives of patients who are poisoned, have a drug overdose, or are in a coma from liver failure. Because of this lack of evidence, Dr Yttri and the NRC argued that these devices need to undergo clinical testing. Continue reading

Testimony of Dr Jennifer Yttri, senior fellow, at FDA Advisory Committee on implanted blood access devices

FDA wanted to change implanted blood access devices, like catheters and cannulas, from a Class III device (highest standards) to a Class II device (lower standards). Senior fellow, Jennifer Yttri, spoke on behalf of NRC about how reclassification would limit the ability of FDA and patients to request more safety and efficacy testing and remove faulty devices from market. Continue reading