FDA to open docket to seek public comments on IOM's report on 510(k) program

Agency continues to improve device review process

The FDA today announced that it will open a public docket to begin receiving public comments on the Institute of Medicine's (IOM) report on the 510(k) program, the most common pathway to market for lower-risk medical devices.

The FDA commissioned the report in September 2009. While none of the IOM's recommendations are binding, the FDA is planning a public meeting in the coming weeks to discuss recommendations made in the report, titled "Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years."  

"We appreciate the IOM's report on the 510(k) program, and agree that the public should continue to feel confident in the medical devices on the market today," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health.

"Medical devices in the U.S. have a strong track record of safety and effectiveness. The 510(k) program has helped support a robust medical device industry in the U.S. and has helped bring lower-risk devices to market for the patients who need them."

"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," Shuren said.

In order for a manufacturer to begin marketing a device subject to 510(k) review, FDA must "clear" a premarket notification (510(k)) demonstrating that the new or modified product is substantially equivalent to another legally marketed "predicate" device.  

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, the FDA 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.

In September 2009, in response to concerns raised by various stakeholders, the FDA undertook an assessment of its 510(k) program to determine what, if any, changes should be made to improve the program and update it so that it adequately addresses the level of current device complexity and today's marketplace.

To that end, the FDA 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 our device review programs in general.

For example, FDA has already:

• issued a draft guidance clarifying when manufacturer changes to a 510(k)-cleared device already on the market warrant a new 510(k) submission
• taken 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.

Still to come:

• 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.