New Institute of Medicine Study Proposes Scrapping of FDA’s 510(k) Submission Process

• By: Staff Editor
• Date: August 19, 2011

The Institute of Medicine (IOM), a respected scientific group and part of the National Academy of Sciences, was asked by the FDA in 2009 to examine specific procedures that the agency might employ to strengthen the 510(k) process. The report, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years, released by the IOM on July 29 has, however, taken the agency by surprised with its suggestion that the 510(k) submission process is ineffective and compromises patient safety.

According to the IOM,

“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… FDA’s finite resources would be better invested in developing a new framework that uses 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 IOM committee also said that the FDA should ensure that the new process allows devices to reach the market in as rapid and least burdensome a fashion as possible.

IOM’s issues with 510(k)

The 510(k) process provides quicker way to evaluate moderate-risk Class II devices than the premarket approval (PMA) that high-risk Class III devices must undergo. The PMA process requires manufacturers to submit results of safety and efficacy tests while the 510(k) clearance generally relies on substantial equivalence that determines only if new devices are sufficiently similar to comparable products that have been previously cleared or were on the market prior to 1975 when the 510(k) process was first put in place by legislative action.

According to the IOM’s report, this reliance on substantial equivalence cannot ensure that devices reaching the market are safe and effective since the majority of the devices used as the basis for comparison were never reviewed for safety or effectiveness.

Industry reaction

According to the New York Times, industry groups had waged an attempt to discredit the report even before its release. The paper reported that groups have also taken legal steps intended to bar the F.D.A. from accepting its recommendations.

Stephen J. Ubl, head of the Advanced Medical Technology Association issued a statement saying: “This would be a disservice to patients and the public health.”

Reaction from patient groups

Patient groups and some medical professionals welcomed the findings in the report, urging the FDA to consider its recommendations.

FDA response

Following the release of the report on July 29, the FDA announced that it would open a public docket to begin receiving public comments on the IOM report.

Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health said: “FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs.”

The agency said that some of the IOM’s recommendations, such as the recommendation to design a new regulatory framework for Class II (moderate risk) devices, may require congressional actions. However, it plans to continue its review of the report and to solicit input from stakeholders regarding the recommendations in the report involving existing FDA authorities.

“Many of the IOM findings parallel changes already underway at the FDA to improve how we regulate devices. These actions, plus a sufficiently funded device review program, will contribute to a stronger program,” said Shuren. “Any major modifications made to the agency’s premarket review programs should be based on sound science and through thoughtful and transparent discussion,” he added.

The FDA said that it is committed to an aggressive action plan designed to improve predictability, consistency, and transparency under the existing statutory framework, not only to the 510(k) process but to its device review programs in general. To support this, the agency cited examples including actions such as:

• Issuing a draft guidance clarifying when manufacturer changes to a 510(k)-cleared device already on the market warrant a new 510(k) submission
• Taking several steps under its “515 Program Initiative” to address all outstanding “preamendment” Class III device types subject to 510(k) review. The CDRH website includes up-to-date information on the status of each of the 25 remaining device types and the agency plans to complete this process by the end of 2012.

The agency also announced that the following changes were in the pipeline:

• Draft guidance to strengthen and streamline the “de novo classification” path to market for novel low and moderate risk devices that are not substantially equivalent to an existing device
• Draft “510(k) Paradigm” guidance clarifying certain aspects of FDA’s 510(k) substantial equivalence review 
• Issue a proposed rule on Unique Device Identifiers this fall. The IOM noted that UDI would be a meaningful change to the agency’s postmarket capability.