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Medical Device Melodrama: A Great Story With a New Plot Twist

Two years ago, FDA Matters urged FDA and Congress to review the 510(k) approval process for moderate-risk medical devices. It was recognition that medical devices are different and that the review process had not been thoroughly re-examined in two decades.

I imagined tweaks, possibly substantial ones, to the 510(k) process. I also predicted that those working with the current system would be comfortable with the changes. FDA and industry have been proceeding along these lines…until last week when the Institute of Medicine (IOM) declared that the current system is so flawed that a new regulatory framework is needed.  

The FDA and industry discussions are being played out on several fronts: industry proposals, FDA proposals, and negotiations over a five-year extension of the Medical Device User Fee Modernization Act. FDA and industry both think the existing system can be improved.

They have different viewpoints. Industry wants a more predictable process that allows applications for moderate-risk devices to be submitted, reviewed and approved more quickly. FDA admits that evolving requirements and standards may be slowing reviews, but also feels the quality of company submissions is a major impediment to faster reviews.

The medical device industry has played its hand well. At their behest, Congress has sent a message to FDA: go slowly as you revise the medical device approval process, avoid mistakes, and do not create any unintended consequences.

FDA has been deft in its responses. It has talked about changes in abbreviated review processes, has proposed a new speedy “high innovation” review track, and been appropriately attentive to Congressional concerns that the process not be rushed. They have been forthright that user fees will need to increase significantly over the next 5-year period for the agency to meet its growing workload and keep pace with 510(k) reviews.

Industry is reluctant to pay increased fees, given their perception that FDA has failed to meet performance targets in the current user fee program. Industry has suggested that maybe a two-year user-fee reauthorization may be preferable to five-years, giving FDA a chance to implement reforms that would, in turn, justify the increased user fee revenue.

The back and forth discussions between industry and FDA have been heated at times, but always mixing disagreement with civility. That is not to minimize the degree of conflict or occasional harsh words. But by government standards, the two sides are working together well and there is reasonable hope of a satisfactory conclusion that will protect the interests of the American public and stimulate innovation in the medical device industry.

Enter the Institute of Medicine. This branch of the National Academy of Sciences had been commissioned by FDA to study the 510(k) approval process. Its long-awaited report was issued on July 29.

Surprisingly, IOM’s report didn’t provide any insights that would help the negotiating process. Instead, they concluded that: FDA should invest in developing a new regulatory framework to replace the flawed 510(k) medical device clearance process. An effective system could not be built on the current framework.

FDA immediately declared: “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.” Industry, too, has a strong interest in improving, not replacing, the 510(k). They agreed with FDA’s rejection of the IOM report.

FDA and industry will continue working and disagreeing with each other, trying to reach agreement. They now have a common enemy: an IOM that insists that a perfect medical device review system should be created….while FDA and industry know that patching the existing one is the only realistic possibility. 


All FDA Stakeholders Affected by Medical Device Reforms      October 31st, 2010

There are so many visible, contentious FDA issues right now….that reform of the medical device approval process has received only a fraction of the attention it deserves. Other centers at FDA and non-device stakeholders need to be watching more closely. FDA Matters is. Read the rest of this entry

“No Surprise” That Medical Devices Are Under Scrutiny           October 1st, 2009

Five weeks ago, I wrote a column entitled, “Re-Evaluating the Medical Device Approval Process.” It was not widely-read. I assumed it was because everyone already knew that a review was underway at FDA with more activity coming. Apparently, I was wrong.  Read the rest of this entry

Re-evaluating the Medical Device Approval Process        August 27th, 2009

Earlier this year, a GAO report concluded that many high risk medical devices have not been adequately reviewed. In June, the House Health Subcommittee held the first of what may be a series of hearings on medical devices. The media appears increasingly interested in medical devices and is raising more questions.

All these events are a prelude to FDA and Congress undertaking a major re-evaluation of the product approval process for medical devices. It would be a relief if FDA could diagnose and treat its own medical device problems, leaving the Congress and the media to watch. Read the rest of this entry


2 Responses to “Medical Device Melodrama: A Great Story With a New Plot Twist”

  1. Amy says:

    Recently returned from Maryland where I testified as a synthetic mesh complication survivor. I am disheartened that the chair of the independent advisory board is the recipient of a $1,000,000 grant from Ethicon, one of the leading manufacturers of synthetic mesh devices for pelvic organ prolapse and stress incontinence. Because the funds were not received in the past 12 months it is not a conflict of interest. I suppose it would be easy to forget who gave you a $1,000,000 after 12 months.

  2. Mark McCarty says:

    It’s a bit difficult to comprehend IOM’s insistence on an outcome they knew is politically and practically impossible. The report mentions the use of the de novo path as an alternate method, but that’s never going to be accepted for low-to-moderate risk devices with a predicate, only moderate-to-high risk devices.

    IOM also references “the performance of comparative devices” as part of “the evidentiary standard” for a device clearance. That, to me anyway, has “predicate” written all over it.

    Is this nuance or a case of having it both ways? This is an important point because (in my view, anyway) the credibility of the entire report rests on this. There really is not much else that describes an alternate moderate-risk device universe.

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