The US Food and Drug Administration (FDA) has moved to reclassify two medical device products under its class II special controls, just months after the FDA Safety and Innovation Act (FDASIA) made it easier for the agency to reclassify older, pre-Medical Device Amendments(MDA) devices.
The two types of devices-external cardiac compressors, also known as chest compressors, and membrane lungs for long-term pulmonary support, also referred to as extracorporeal membrane oxygenation (ECMO) devices-have been legally marketed for decades.
Prior to the passage of the 1976 MDA, devices were more or less free to be marketed with few restrictions. The passage of the MDA grandfathered in many of these devices, but any devices first marketed after 18 May 1976 were automatically classified as class III (high-risk) devices, which require a premarket approval (PMA) application to be legally marketed.
Based on "new information," however, FDA said it has proposed reclassifying the two device types as class II devices with special controls, which would allow medical device manufacturers to have subsequent devices cleared through FDA's 510(k) substantial equivalence pathway instead of the PMA pathway, which typically requires clinical trials to support approval.
Both devices share a similar regulatory history, having been classified as class III in 1979 due to their status as life-supporting and -sustaining devices. At the time, "Sufficient information did not exist to determine the adequacy of general controls or to establish standards to provide a reasonable assurance of the safety and effectiveness" of either device, FDA wrote. The classifications went largely unchanged until 2009, when FDA solicited information from the manufacturers of the devices, starting a process of major revisions.
The 8 January 2013 Federal Register notices announcing the changes are similar except when it comes to the details of each device's unique class II special controls.
External cardiac compressor controls would apply to all such devices with the exception of CPR aid devices capable of guiding rescuers to meet the American Heart Association's guidelines for CPR, which would not be required to meet premarket notification (510(k)) guidelines. The device category at large, when subject to adequate controls, "provides reasonable assurance of the safety and effectiveness of the device," FDA wrote.
Controls for the devices will include instructional labeling, performance testing requirements, electrical and electromagnetic compatibility safety testing, biocompatibility, software validation and hazard analysis, and human factors testing (evidence of how a device is used in real-world conditions by non-experts).
Membrane lung devices, meanwhile, would cease to be regulated as an anesthesiology device, and instead be regulated as a cardiovascular device under 21 CFR 870. This change will "better align this device type with other, similar types of cardiovascular devices and align the review responsibilities for this device types," FDA wrote.
Though the use of the device is potentially associated with a myriad of serious risks, FDA and its advisory panel on the device both concluded that risks could be mitigated with appropriate class II special controls, including proper design taking into account the device's intended use, the biocompatibility of the device with human subjects, testing the product's shelf life and sterility, in vivo evaluation of the device, detailed labeling and nonclinical performance evaluation.
Both proposed reclassifications are subject to public comment for the next 90 days (until 8 April 2013).