We strongly support the FDA proposed order that will require the premarket approval application (PMA) for Automated External Defibrillators systems (AEDs). A study of high-risk recalls of medical devices from 2005-2009, Medical Device Recalls and the FDA Approval Process, published in the Archives of Internal Medicine in 2011, noted that cardiovascular devices comprised the largest category of high-risk recalls. More than 350,000 Americans may need an AED this year, which is why we do not support the FDA exercising enforcement discretion for 15 months.
More than 95% of medical devices on the market were not required to be proven safe or effective. Less than 5% are required to be studied in clinical trials. Our goal is to improve the safety and effectiveness of all medical devices sold in the U.S. and educate healthcare professionals and patients about known and unknown benefits and risks of each device.
We welcome the opportunity to comment on the proposed rule for the unique device identifier (UDI) system. The creation of an effective and efficient UDI system is urgently needed to reduce the harm to patients and consumers from unsafe and defective medical devices.
We oppose FDA’s proposal to allow a Product Development Protocol (PDP) instead of a PMA for this device because PDPs are for devices where a sponsor comes to an “early agreement with FDA as to what would be done to demonstrate the safety and effectiveness of a new device.” FDA has stated unequivocally that SWD devices “have not been shown to be safe and effective” therefore, the devices have no public health benefits, and that also rules out the use of a PDP.
We have concerns about clearing a group of devices through the 510(K) process for one use and through a more rigorous process for a different use. In addition, the Food and Drug Administration’s (FDA’s) proposal for these devices raises fundamental questions about whether the Center for Devices and Radiological Health is following the law regarding the regulation of devices that are life-sustaining or life-supporting.
We have concerns about the use of the de novo process for high-risk medical devices. Although intended for low- and moderate-risk devices, too many devices that are high-risk are cleared through the 510(k) process and later found to cause life-threatening adverse events.
As members of the Patient, Consumer, and Public Health Coalition, we want to express our strong support for H.R. 3847, the Safety of Untested and New Devices (SOUND Devices) Act of 2012. This legislation will protect the public from avoidable harms caused by unsafe devices that should never have been cleared for sale in the first place. It will also help to ensure that decisions on device safety are based on more reliable information.
As members of the Patient, Consumer, and Public Health Coalition, we strongly oppose the reclassification of External Pacemaker Pulse Generator Devices (Product code DTE) from class III (high risk devices) to class II (moderate risk devices). These devices are among the “pre-amendment” class III devices, which have been cleared by the less-than rigorous 510(k) process. External Pacemaker Pulse Generator Devices should remain class III devices and they should require Premarket Approval Applications (PMAs) because they are life-sustaining devices.
We strongly support the FDA’s proposal to require the filing of a premarket approval application (PMA) for the implantable pacemaker pulse generator, a class III pre-amendments device. We agree with report on the 510(k) process’s recommendations 7-8, which state that the FDA should promptly call for PMA applications or reclassify the Class III devices that are still cleared by the 510(k) process. The implantable pacemaker pulse generator is one of those Class III devices alluded to by GAO and IOM.
We support the Institute of Medicine’s (IOM) efforts to strengthen the 510(k) clearance process for medical devices, but believe that the concerns expressed by the IOM regarding the lack of proof of safety and efficacy can be addressed by substantially improving 510(k) criteria, policies, and implementation. We strongly encourage CDRH to incorporate the concerns of the IOM report into substantial efforts to improve the 510(k) process, and to better ensure the safety and effectiveness of implanted medical devices by requiring that they all be reviewed through the PMA process instead.