BREAKING NEWS: IOM Committee On 510(k) Review Program: Dump It (July 2011)

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IOM Committee On 510(k) Review Program: Dump It  

The Institute of Medicine committee charged with reviewing FDA's 510(k) device pre-market review program is urging the agency to ditch the 35-year-old program and start fresh.

After 16 months of work, the IOM committee, chaired by David Challoner, VP for health affairs emeritus at University of Florida, released its long-awaited, and sure-to-be controversial, recommendations July 29 in a 245-report titled "Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years."

"The 510(k) clearance process is not intended to evaluate the safety and effectiveness of medical devices, with some exceptions," the IOM committee wrote. "The 510(k) process cannot be transformed into a pre-market evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to any previously cleared device."

The IOM panel urged FDA to design a new method for assessing moderate-risk devices, perhaps based on a modified version of the current "de novo" review process.

"A move away from the 510(k) clearance process should occur as soon as reasonably possible," IOM wrote in its report.

Given the limitations of the current de novo process, which first requires a novel, moderate-risk device to be found not substantially equivalent to a previously cleared product, FDA should consider piloting a modified de novo process to determine whether it could replace the 510(k) program entirely, IOM said. The agency is already working to reform the de novo process to address some of its limitations.

IOM: This Is Not A Public Health Crisis

Currently, to gain 510(k) clearance, a moderate-risk device must demonstrate substantial equivalence to a cleared predicate device (or devices) by showing that it has the same intended use and same technological characteristics, or that any different technological characteristics do not raise new questions of safety or effectiveness.

About a third of new devices each year reach U.S. customers via the 510(k) pathway, IOM notes.  

But despite IOM's sweeping proposal, "the committee does not believe that there is a public-health crisis related to unsafe or ineffective medical devices," the report adds.

FDA quickly countered that it does not believe the 510(k) process should be eliminated, "but we are open to additional proposals and approaches for continued improvement," the agency said.

FDA plans to open up a public docket to receive comments on the IOM report, and will hold a public meeting in the coming weeks.

  1. "We ... agree that the public should continue to feel confident in the medical devices on the market today," CDRH Director Jeffrey Shuren said in a July 29 statement.

FDA Calms Fears Ahead Of Report

Concerns about IOM's recommendations began mounting in the device industry and in Congress well before release of the report.

The committee's recommendation to scrap the current 510(k) review program is likely to be viewed as a worst-case scenario to the industry, which has argued that the program should remain essentially intact.

FDA Commissioner Margaret Hamburg addressed worries about the upcoming report at a July 28 hearing of the Senate Health, Education, Labor and Pensions committee. The commissioner had not yet seen the final IOM report at the time.

"We will welcome the IOM report and its recommendations, but they are just recommendations," Hamburg emphasized. "We will review them internally and engage with stakeholders to get their perspectives on the recommendations."

Any changes FDA does make based on the report, "would be done in an open and transparent process with lots of opportunity for discussion, for notice and comment and feedback," Hamburg told the Senate committee.

FDA said July 29 it would solicit input on the IOM recommendations that involve existing FDA authorities.

The broad-based overhaul recommended by IOM could likely require statutory changes, so members of Congress are another important audience for the new report.

IOM Says FDA Goals, Statute Do Not Align

The report was commissioned in 2009 by FDA.

FDA had asked IOM to assess whether the 510(k) program was optimally protecting patients and promoting innovation, and if not, what changes should be made. FDA had noted that the primary goals of the 510(k) program are to bring "safe and effective" devices to market and "promote innovation."

But the IOM committee said it had a hard time completing the task because FDA's goals for the 510(k) program do not line up with the program's statutory framework.

"The committee struggled with how to address the conflict between the legislative framework of the program and the FDA's stated goals," IOM wrote.

And since the 1976 implementation of unique medical device legislation, subsequent bills have only further limited what data FDA could ask for in 510(k) submissions, the group said.

Note To FDA: Don't Invest In 510(k)

FDA needs a brand-new framework to ensure the safety and effectiveness of class II, moderate risk medical devices, the IOM committee decided.

"The committee does not believe that further investment in the 510(k) process is a wise use of the FDA's scarce resources," the group stated.

The new framework should be based on sound science and risk-based, IOM said.

It may include some comparison to similar devices as a component of the review, the group added.

FDA's quality system regulations, especially those related to design control, should be integrated into the new framework, IOM continued. And the new framework should incorporate a more thorough review of device labeling and a system for tracking labeling changes.

IOM did not directly address the seven controversial 510(k) reform proposals that FDA had asked the committee to consider in January. (See "FDA 510(k) Reform Plan Yields Mixed Readings" - "The Gray Sheet" Jan. 24, 2011.)

  1. "Because of time constraints, the committee was unable to study fully the seven recommendations referred to it," committee chair Challoner wrote in a July 20 letter to Shuren.

IOM Flags Post-market Weaknesses

IOM also criticized substantial weakness in post-marketing surveillance of medical devices, noting that FDA does not even use all the tools and authorities at its disposal to ensure the safety of devices after they reach the market.

The agency is already developing new methods of post-market safety surveillance through its fledgling Sentinel safety data monitoring project. (See "Sentinel Pilot Begins Scanning Drug Data, But Device Work Still Exploratory" - "The Gray Sheet" Jan. 24, 2011.)

The IOM committee also called on FDA to finish downclassifying or requiring PMAs for the remaining 510(k) device types that were on the market prior to 1976 and have never been formally reclassified.

[Editor's note: More news on the medical device and diagnostics industries is available each week in "The Gray Sheet." Visit our website to sign up for a free trial, or call 1-800-332-2181.]

- Jessica Bylander ([email protected])

Copyrights 2009. Association of Indian Medical Device Industry.