The 510(k) system is a key regulatory pathway for industry, providing an FDA pathway to market for new devices that are substantially equivalent to a device already legally on the market. Approximately 3,500 to 4,000 510(k)s are submitted each year in comparison to 30-50 PMAs. Efforts to make substantial changes to the 510(k) system have been gaining momentum over the past few months due to concerns about the potential for high risk or unsafe devices to be cleared through the 510(k) process rather than the more complex PMA process.

FDA has been involved in at least three linked efforts all aimed at assessing and revising the 510(k) program. First, in 2009, FDA started a series of four internal task forces charged with examining the 510(k) program and suggesting changes to "strengthen" that process. Second, in September 2009, FDA commissioned the Institute of Medicine (IOM) to conduct a study to recommend legislative, regulatory or administrative changes to the 510(k) system to optimize its ability to advance public health and innovation.

Third, and of more immediate interest, FDA is in the midst of its own process of developing, vetting and then implementing changes to the 510(k) system. As part of that process, FDA held a public meeting on February 18, 2010, to provide an opportunity for the public to comment on the current 510(k) system. Prior to this meeting, FDA identified four key areas of interest to FDA:

  • Issues relating to predicate devices;
  • Issues relating to new technologies and scientific evidence;
  • Issues relating to "high volume" 510(k)s (e.g. abbreviated and special 510(k)s); and
  • Post-market surveillance.

The meeting was attended by senior management at the Center for Devices and Radiological Health (CDRH) and from the Office of Device Evaluation (ODE). The meeting started with FDA reviewing its list of the primary issues, but FDA did not give any indication of any specific changes it might be contemplating.

The bulk of the meeting was devoted to short (5-minute) presentations by members of the public. The vast majority of all comments were supportive of the 510(k) system but were critical of FDA's current implementation of the 510(k) system. Commentators discussed issues with predicate selection, defining substantial equivalence and data requirements. A number of speakers expressed concerns over lengthening review times, changing data requirements and uncertainty over classification. The De Novo process also was subject to substantial criticism. At several points during the meeting speakers asked FDA to clarify its rationale for driving changes to the current 510(k) system and requested FDA release any evidence of 510(k) clearances of unsafe products.

At the end of the meeting, FDA and selected panelists held a roundtable discussion that amplified the issues raised during the day. Diana Zuckerman from the National Research Center for Women and Families was particularly vocal in her criticism of the 510(k) system. She challenged the concept of substantial equivalence and firmly believes that there are a plethora of unsafe products being cleared though the 510(k) system. FDA did not respond to any of the criticisms or give any meaningful indication of possible changes to the 510(k) system. In summary, this public meeting unfortunately did not provide any new details about any specific proposed changes, but did reinforce the need for continued advocacy about the strengths and successes of the current system by concerned stakeholders.

Key opportunities for stakeholder engagement over the next year are:

  • March 1: initial IOM 510(k) task force meeting
  • March 19: comments on the Federal Register notice regarding the 510(k) system due
  • May 31: CDRH recommendations released
  • July 31: FDA implementation plan released
  • September 30: implementation of FDA plan commences
  • March 2011: IOM report due to Congress

During the next year, we can expect substantial activity on the 510(k) front as various groups seek major changes to the system. We will continue monitoring this important issue and keep you apprised of relevant developments.