The 510(k) premarket notification process provides a clearance pathway for new, low-risk medical devices to be sold in the US by proving to the US Food and Drug Administration (FDA) that a proposed product is substantially equivalent to another, existing, legally marketed device. But the process has come under fire from critics in Congress and others who have called it a "loophole" that allows devices onto the market without putting them through a rigorous approval process. Bolstering this perception is the fact that a number of devices cleared through the process have been the subject of high-profile safety recalls over the past few years.

In January 2011, FDA announced a plan to improve the program and has since released additional new and revised guidance documents, but this has not silenced the program's detractors. Notably, in July 2011, the Institute of Medicine (IOM) released a scathing report recommending FDA eliminate the program altogether and develop a new regulatory framework for the devices currently cleared through the 510(k) process. Just this summer, in August 2012, Rep. Edward Markey (D-MA) and Sen. Jeff Merkley (D-OR) sent a letter to FDA, calling additional attention to safety concerns and requesting that more information about cleared devices be made available to the public.

"The 510(k) program has been under fairly intense criticism from some quarters," said John Manthei, JD, a partner at Latham & Watkins, and the leader of a session entitled Revisions to the 510(k) Process to be held during the upcoming 2012 RAPS: The Regulatory Convergence. "I would say that the program that exists today is not the program that will exist nine months from now."

Manthei says he doesn't think all of the criticism of the program is deserved, but there is room for improvement. Medical device makers have acknowledged the process has shortcomings even while defending the 510(k) program as an important component of regulatory oversight of devices.

FDA's steps aimed at improving the process-such as the new and revised guidance documents-have provided some additional clarity, but industry advocates continue to express concern about the transparency and predictability of the 510(k) process during this transitional period. The challenge for industry is understanding what FDA needs, says Manthei. And revisions to the process mean increased uncertainty.

The recent passage of the new Medical Device User Fee Act (MDUFA) as part of the Food and Drug Administration Safety and Innovation Act, and the passage of the Budget Control Act (BCA) add several additional elements of uncertainty. MDUFA would likely bring some changes to FDA's handling of 510(k) submissions, and sponsor companies would need to adjust accordingly. However, the BCA puts the future of all FDA user fee programs in doubt, including MDUFA, as the user fees could be subject to sequestration.

Assuming MDUFA takes effect as planned, it should give FDA additional resources to put toward review of all devices. Agency officials have cited a lack of resources as a factor in slow review times, so the changes likely would be aimed at increasing efficiencies and speeding up processes, and be well-received by industry. But that may not be the end of changes-and continued uncertainty-for the device review process or the 510(k) program.

"I think we'll likely see other reforms follow MDUFA and those will have implementation issues that industry will closely track," said Manthei.

The 2012 RAPS session on 510(k) revisions will present a panel discussion featuring Christy Foreman, director of the Office of Device Evaluation in FDA's Center for Devices and Radiological Health; Tamima Itani, PhD, RAC, FRAPS, vice president of global regulatory affairs at Boston Scientific; and Mark B. Leahey, president and CEO of the Medical Device Manufacturers Association, bringing together multiple perspectives, including FDA and the device industry, on the evolution of a process that is changing and uncertain, but is critically important for all stakeholders.

2012 RAPS: The Regulatory Convergence will be held 26-30 October in Seattle. For more information about the conference and to find out more about the Revisions to the 510(k) Process session or other conference programming, please see the 2012 RAPS webpage.