Author name: PCeditor

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.