FDA Review Process and Recalls of Medical Devices

In 1938, when the US Congress mandated that medical products had to demonstrate safety and effectiveness, the law applied only to drugs, not medical devices. It was not until 1976 that the US Food and Drug Administration (FDA) was given the authority to regulate all medical devices with the enactment of the amended Food, Drug, and Cosmetic Act. The act was amended in response to deaths and infertility caused by the Dalkon Shield and other contraceptive intrauterine devices. The 2 goals taken into consideration by the FDA and the Congress during passage of the amended law were providing “the public reasonable assurances of safe and effective devices” while avoiding “overregulation” of the industry. In the 1976 law, Congress included a premarket approval (PMA) process for devices based on the model in place for new drug applications used for pharmaceuticals. PMA submissions require extensive testing, including “valid scientific evidence” that “provide[s] reasonable assurance that the device is safe and effective for its intended use.” Because thousands of devices that met the FDA definition for medical devices were already marketed when the 1976 law was enacted, the new law included an alternative pathway to PMA, called the 510(k) provision. The 510(k) was intended to offer a less burdensome route to enable newer versions of existing devices to enter the market; it did not require clinical trials or manufacturing inspections to demonstrate safety and efficacy. The sponsor had only to demonstrate that the device was substantially equivalent in materials, purpose, and mechanism of action of another device already on the market in May 1976. The previous device was considered a predicate device with which the new device would be compared. In 2002, the Medical Device User Fee and Modernization Act was passed and interpreted by the FDA to shift the regulatory standard to “the least burdensome approach in all areas of medical device regulation,” modifying the definition of substantially equivalent to include products made from different materials and using a different mechanism of action if they were determined to have a similar safety profile. According to researchers, in recent years, the FDA has used the 510(k) provision as the primary mechanism for new device clearance, reviewing only 1% of medical devices by the more rigorous PMA process. The researchers recently conducted a study to examine how often the different approval or clearance processes were used for medical devices that were subsequently recalled for life-threatening problems. They reported results of the study in Archives of Internal Medicine [2011;171(11):1006-1011]. The researchers utilized the FDA’s high-risk List of Device Recalls from January 2005 through December 2009. During that study period, the FDA included 115 names of recalled devices on their high-risk list. Of those 115 recalls, the agency designated 113 as Class I recalls, defined as the highest risk based on information provided to the agency by health professionals, researchers, patients, or device companies. In fiscal year 2006, for example, the FDA received reports of 116,086 potential device-related injuries, 2830 potential device-related deaths, and >20,000 adverse events reports concerning medical devices. Those reports are used by the FDA to aid in the decision as to whether a device should be recalled due to a high risk to patients. In the 113 Class I recalls during the study period (could cause serious health problems or death), only 19% (n=21) had been approved through the PMA process; 71% (n=80) had been cleared through the 510(k) process; 7% (n=8) were exempt from FDA regulation but were registered with the agency; and 3% (n=4) were counterfeit devices or categorized as “other” and did not go through any of the 3 processes for approval, clearance, or registration. The largest recall category was cardiovascular devices, with 35 separate recalls accounting for 31% of devices on the high-risk recall list. Of those, 66% (n=23) had been approved through the 510(k) process. Despite the FDA law requiring nearly all Class III devices to be approved through the PMA process, 12% (n=13) of the recalled 510(k) high-risk recalled devices were designated as Class III. (Class III devices are defined by the FDA to pose the greatest potential risk and include items such as implantable pacemakers, stents, heart valves, and HIV diagnostic tests.) The researchers concluded that, “Most medical devices recalled for life-threatening or very serious hazards were originally cleared for market using the less stringent 510(k) process or were considered so low risk that they were exempt from review (78%). These findings suggest that reform of the regulatory process is needed to ensure the safety of medical devices.”