IOM Report Suggests Overhaul of 510(k) Program; FDA Responds with Request for Public Comment

Aug 01, 2011   

The Institute of Medicine (IOM) recently released a report, Medical Devices in the Publics Health: The FDA 510(k) Clearance Process at 35 Years, which summarizes the IOMs findings regarding the U.S. Food and Drug Administrations (FDA) 510(k) premarket notification program.

The FDA is responsible for ensuring that medical devices on the market are safe and effective for the publics use. In order to market a medical device in compliance with the FDAs regulations, device manufacturers must obtain either FDA approval of a premarket application (PMA) or FDA clearance of a 510(k) premarket notification. Under the 510(k) process, the FDA may “clear” a medical device if it finds that the device is as safe and effective as a predicate medical device. This 510(k) process is the pathway by which most lower-risk devices reach the market.

The FDA commissioned the IOM to review the current 510(k) program after receiving complaints from industry and consumers about the viability of the program. While reviewing the 510(k) program, the IOM was asked to consider the following two questions:

  • Does the current 510(k) process protect patients optimally and promote innovation in support of public health?
  • If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process optimally?

The IOM committee assessed the overarching structure of the 510(k) process and its ability to sufficiently monitor and oversee the safety and efficacy of medical devices on the market. “Premarket review, including the 510(k) process, and post-market oversight”from product labeling regulations to the reporting of adverse events associated with use of a device”make up a comprehensive medical device regulatory system.”

The committee identified substantial problems with the FDAs current post-marketing surveillance of devices. Because the FDA lacks a robust post-marketing surveillance system, the IOM recommended that the FDA “develop and implement a comprehensive strategy to collect, analyze, and act on medical device aftermarket performance information.”

Overall, the IOM committee determined that the FDAs current 510(k) process is flawed on its legislative foundation and suggested that the FDA completely overhaul its 510(k) process. “Rather than continuing to modify the 35-year-old 510(k) process,” the committee concluded that “the FDA’s finite resources would be better invested in developing an integrated premarket and post-market regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.” In an effort to protect patients, healthcare providers, industry, and the FDA, the committee suggested that the new regulatory framework should:

  • be based on sound science;
  • be clear, predictable, straightforward, and fair;
  • be self-sustaining and self-improving;
  • facilitate innovation that improves public health by making medical devices available in a time manner and ensuring their safety and effectiveness throughout their lifecycle;
  • use relevant and appropriate regulatory authorities and standards throughout the life cycle of devices to ensure safety and effectiveness; and
  • be risk-based.

(For the full text of the IOMs Report Brief, click here.)

In response, the U.S. Food and Drug Administration (FDA) announced that it will request public comments on the IOMs report about the current 510(k) premarket notification process, see announcement here. Despite the IOM committees determination the current 510(k) premarket notification process is highly flawed and fails to adequately monitor the quality of medical devices on the market, the FDA maintains that “medical devices in the U.S. have a strong track record of safety and effectiveness” and, therefore, “the 510(k) process should not be eliminated.”

Jeffrey Shuren, Director of the FDAs Center for Devices and Radiological Health (CDRH), stated that “many of the IOM findings parallel changes already underway at the FDA to improve how [the FDA] regulate[s] devices.” This new plan, the CDRH Plan of Action for 510(k) and Science, is designed to improve the FDAs predictability, consistency, and transparency in reviewing medical device submissions.

For example, the FDA recently issued draft guidance clarifying when a manufacturers changes to a 510(k)-cleared device already on the market necessitate a new 510(k) clearance, as we previously reported here. In addition, the FDA intends to issue a draft guidance of the “510(k) Paradigm,” which will aim to clarify the FDAs 510(k) substantial equivalence review, and a draft guidance that strengthens and streamlines the “de novo classification” path to market for medical devices that are not substantially equivalent to an existing predicate device.

Although the FDA disagrees with the IOM committees recommendation to abandon the current 510(k) program, the Agency recognizes that certain areas are in need of improvement. For this reason, the FDA has invited the public to comment on the results of the IOMs report. In doing so, the FDA aims to find alternative proposals and approaches to help improve its device review programs.

Fuerst Ittleman will continue to monitor the developments and changes to 510(k) premarket notification process. For more information, please contact us at