FDA Medical Device Clearance Process Criticized

The Institute of Medicine (IOM) released a study of the 510(k) clearance process for medical devices.Their answer to the question: “Does the 510(k) clearance process provide a reasonable assurance of safety and effectiveness?” was: “The 510(k) clearance process is not intended to evaluate the safety and effectiveness of medical devices with some exceptions.The 510(k) process cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to any previously cleared device.” As one of the committee members at the IOM briefing said, “510(k) logic is fundamentally flawed.”

Medical devices are divided into three classes that, roughly speaking, correspond to levels of risk and needed safety controls, Class I being lowest and Class III highest. 510(k) clearance allows Class II devices to come to market without a premarket approval (PMA) process. 510(k) clearance can also be used for certain Class I and Class III devices, but that is not extensively addressed by this report. Two-thirds of all new devices (typically Class I) are exempt from review. About one-third goes through 510(k) clearance. Only 1 percent of all new devices enter the market via the PMA pathway.

A manufacturer can obtain 510(k) clearance by notifying the FDA that the device is substantially equivalent to an older, approved Class II device (predicate). The new device would then be cleared for marketing subject to the same requirements as the predicate device. To be substantially equivalent, the device has to be for the same intended use as the predicate, with the same technological characteristics (or different characteristics that are demonstrated to be as safe and effective as a predicate) and does not raise different questions of safety and efficacy than the predicate device.

The primary criticism by the IOM is that the clearance process does not include an evaluation, either pre-market or post-market, of the product’s safety. In cases in which the product is truly a clone of a currently marketed device, substantial equivalency is not necessarily an incorrect standard. However, substantial equivalence does not guarantee that the device poses the same risks and performs similarly to an older device, particularly when the device is a chimera of multiple predicates. And the manufacturer can use as a predicate an old, discontinued device or a device that was approved but never marketed.

There have been instances where a new 510(k) device, though based on a predicate, was found in practice to have a different risk profile. For example, many metal-on-metal hip systems were approved via 510(k), but the FDA is now conducting further review ( based upon adverse events in both the USA and the UK.

The IOM committee recommends increased premarket and postmarket regulation of these devices. To avoid tying up all new devices in the more costly and lengthy PMA process, the premarket review needs to be appropriate to the projected risk of the device. The report emphasizes the importance of postmarket surveillance — both to assure that the primary use is same as the predicate and to rapidly identify new risks. Improved postmarket surveillance may allow a quicker premarket process without needlessly increasing risk to patients. With appropriate surveillance, postmarket detection may occur after the same number of adverse events as it would in a large premarket study.

Motivation for assurance of primary use comes partially from the marketing rules. Marketing for “off-label use” is different for devices than drugs. While the FDA regulates and restricts off-label promotion of prescription drugs and restricted devices (typically Class III devices), the Federal Trade Commission regulates promotion of virtually all Class II devices. The report includes the example of biliary stents, where the primary use in practice systematically differed from the 510(k) application.

Many facilities, including hospitals, are required to report to the FDA and/or manufacturer when a device has or may have caused or contributed to a patient’s death, serious illness or serious injury (21CFR803.3 through 803.33). While the initial report may go to either the manufacturer or the FDA, an annual report of these events goes to the FDA. Providers can enhance the FDA’s ability to monitor devices by not only identifying required events but also others that may indicate emerging device issues.  Members can report these events to CHPSO. CHPSO is collecting the experience of many hospitals and will be looking for areas of concern.


Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process. Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years. Washington, D.C.: National Academies Press; 2011:245.