Back in late July of this year, the Institute of Medicine (IOM) recommended that FDA replace the 510(k) medical-device clearance process with something brand new. (Under current regulation, to obtain 510(k) clearance, a manufacturer must demonstrate that the device is substantially equivalent to a device that was in legal commercial distribution in the United States before May 28, 1976, or to a device that has been determined by FDA to be substantially equivalent.) The committee stated that FDA’s resources would be better used in the development of a new framework using both premarket clearance and improved postmarket surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II devices throughout the duration of their use. “The 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk Class II devices and cannot be transformed into one,” the IOM committee concluded in its report.

510(k): Imperfect, but worth defending? Since its release, IOM’s report, titled “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years,” has garnered much attention and discussion among industry and those who monitor it, and the recommendation to abandon 510(k) has been met with some derision.
In a letter sent to FDA’s Division of Dockets Management on September 30, the Advanced Medical Technology Association (AdvaMed), wrote that while it commends the IOM committee’s efforts and believes that the report “contains a number of valuable observations and recommendations,” including instituting an internal quality-assurance program in CDRH, AdvaMed nevertheless “strongly disagrees with [IOM’s] central recommendation to abandon the current 510(k) program and replace it at some unknown date with an untried, unproven, and unspecified new legal structure.”
In an interview with IVD Technology in October, AdvaMed’s executive vice president of technology and regulatory affairs, Janet Trunzo, echoed that statement: “We were surprised by that recommendation. The IOM opened up some opportunities to submit any kind of information [related to 510(k)]; they were very willing to accept any kind of commentary and information. They made an information-gathering effort. We were just surprised that the key recommendation after all that work was that we should scrap the 510(k) program and that FDA should not expend any more of its resources on making improvements to it.” She said she could not speculate on how the IOM arrived at that recommendation.
Glen Freiberg, RAC, a longtime regulatory, clinical, and quality consultant for the medical device and diagnostic industry, believes that the current 510(k) process could “work quite well to meet everyone’s objectives” with improved management. As an example, he points to FDA’s recent draft guidance for infusion pumps. “Infusion pumps traditionally went through the 510(k) system with bench testing and without clinical trials,” he says. “If you take a look at the recall database, you will be amazed to learn how many pump vendors have had recalls, for a variety of reasons.” He says that while the new draft guidance for infusion pumps “is not perfect,” it does show how FDA can flexibly address safety and effectiveness under the current 510(k) paradigm. In short, this draft guidance is evidence in support of keeping and working with 510(k).

Disagreement on how to keep unsafe products off the market. Reliance on substantial equivalence to already-cleared products or products on the market prior to 1975 cannot assure that devices reaching the market today are safe and effective, the IOM committee concluded. The majority of the devices used as the basis for comparison were never reviewed for safety or effectiveness, according to IOM. This does not mean that they or the devices that followed them are unsafe, IOM adds, and the continued use of many of these products in clinical practice provides a level of confidence in their safety and effectiveness. But 510(k) clearance does not determine a device to be safe or effective, the report asserts.
Freiberg responds, “To date, stakeholders have been looking in the wrong direction. Specifically, everyone is looking at the regulations and intent of 510(k) without having conducted an effective system management assessment.” He contends that most medical device safety and effectiveness problems that come up result not from issues within 510(k) itself but from manufacturing and quality problems at individual production sites. “A more appropriate approach,” he suggests, would be for CDRH to recognize that the issues raised in recalls should be compliance-oriented rather than clearance-oriented. “That’s not to say there is no role for clinical data in traditional device submissions,” he adds, “but the authority and resources for this aspect of the historical device problems should be delegated to the field-inspection system via improved compliance-policy guides to the investigators.”
Freiberg summarizes this way: “FDA should be defending the 510(k) substantial equivalence notification procedure for what it is-demonstration of equivalence-while concurrently boosting enforcement of quality systems via inspection and enforcement rather than via the review process.”