Devices

We are writing to express our opposition to the draft guidance Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices. With this draft guidance, the FDA is notifying manufacturers and others that it “does not intend to enforce compliance with regulatory controls that apply to” medical device data systems (MDDS), medical image storage devices, and medical image communications devices.  The FDA has stated it is using its enforcement discretion on these devices because of “the low risk they pose to patients and the importance they play in advancing digital health.” We strongly disagree.

We 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.

The draft guidance states that the use of consensus standards will “streamline premarket review” and “facilitate market entry for safe and effective medical products.”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process, but are concerned about the potential for lowering the standards for safety and effectiveness since the draft guidance states that one of the purposes of declaring conformance with a consensus standard is to “reduce the amount of supporting data and information that are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.” We would strongly oppose any reduction in the already limited information regarding safety, effectiveness, or substantial equivalence.

We are writing to express our strong concerns about the draft guidance for the “Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval.” The standards for PMA are currently much lower than for prescription drugs, despite the fact that the 1% of devices approved through the PMA process are life-saving and life-sustaining products, which many prescription drugs are not.  The draft guidance has the potential to lower those standards even more, by increasingly relying on postmarket safety and effectiveness data rather than pre-market data, thus putting patients at greater risk.

We do not support the draft guidance for the “Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions.” The standards for PMA are already substantially lower than for prescription drugs. Most PMA devices are approved through supplements that do not require clinical trials. Original PMA clinical trials are often small and short-term with limited use of control groups.  And yet, the draft guidance lowers the bar for certain PMA medical devices even further.

This proposed indication for the HPV test would represent an unprecedented and significant shift in clinical practice that would affect millions of women for the majority of their adult lives.  With the health of so many at stake, we strongly urge the FDA to reject the application for this expanded indication, until evidence clearly indicates that this will not reduce the effectiveness of screening for cervical cancer.

We strongly support the FDA’s proposed order for Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Temporary Ventricular Support devices to remain in Class III with Premarket Approval applications (PMA) required. The evidence of safety and effectiveness for these indications has not been established, and the benefit/risk profile for these devices is “unknown.”

We strongly support the FDA’s proposed order for Intra-Aortic Balloon and Control Systems (IABP) devices used to treat septic shock or pulsatile flow generation (Other Specific Intended Uses) to remain in Class IIIwith Premarket Approval applications (PMA) required. The evidence of safety and effectiveness forthese indications has not been established.  As the FDA noted in its assessment of the device, there is no “theoretical or demonstrated benefit to using the intra-aortic balloon and control systems for this clinical syndrome.”

We oppose the FDA proposed order that will reclassify stair-climbing wheelchairs (a preamendment 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.

We are writing 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.  Our coalition includes consumer groups, patient groups, public health experts, medical professionals, and scientists who are dedicated to ensuring that all medical products sold in the U.S. are safe and effective.