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All FDA Stakeholders Affected by Medical Device Reforms

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.

The key area being examined is how FDA regulates Class II (medium risk) devices. Generally, they require a 510(k) Premarket Notification to be marketed. Under this process, a sponsor must show that a device is “substantially equivalent” to a device already marketed. The 510(k) is significantly less rigorous and time consuming than a full Product Marketing Application (PMA), the medical device equivalent of a drug NDA or a biologics BLA. A related area under review is the broad interpretation that “substantially equivalent” has been given.

Given the realities of the medical device industry, such an abbreviated process is necessary. In pharmaceuticals, product life cycles are typically 8 to 10 years or more after approval. In contrast, devices are being improved constantly. Products, as approved, might be on the market only 18 months to 2 years before the devicemaker is ready with improvements.

Thirteen months ago, FDA released an internal review of the agency’s (mis)handling of the 510(k) device approval of a product from a company named ReGen. The report provided an inventory of issues to be re-evaluated and immediate impetus for FDA to improve the medical device approval process.

At the time, I expressed hope that FDA could formulate changes by itself, rather than give Congress a reason to consider amendments to the medical device statute. FDA also saw it this way and asked the IOM to formulate recommendations while the agency proceeded internally to develop its own proposals.

FDA released its recommendation in August, with public comments due in October. Industry agreed with some of the proposals, but was unhappy about the breadth of FDA’s initiative and some specific recommendations. Some consumer groups thought the FDA proposals did not go far enough.

As a result of industry concerns, a bipartisan group of Members of the House Energy and Commerce Committee have written to Commissioner Hamburg asking FDA to slow down its implementation of changes. The group was careful not to endorse or criticize FDA’s actions. The Members requested more transparency and reminded FDA of the importance to patients and the economy of medical device innovation. Similar caution and concerns are being expressed to FDA from the Senate side.

Why should other parts of FDA and non-device stakeholders care about these developments? First, FDA showed a rare capacity for self-criticism in the ReGen report. These types of inquiries will occur elsewhere at FDA when system failures occur.

Second, FDA has decided that it has the insight and statutory authority to substantially overhaul a major approval pathway. It has been doing so without close Congressional scrutiny. If food safety reform legislation isn’t enacted this year, FDA may need to proceed in a similar manner. Other efforts may eventually be undertaken with drugs, biologics and other medical products.

Third, Congress may be taking a more bipartisan approach to FDA. A system of checks and balances may be evolving between Congress and FDA, where the agency is given room to develop policies under the arms-length scrutiny of Congress.

Fourth, the current effort is reminiscent of Representative Eshoo’s successful efforts to add biosimilars legislation to health care reform. The key was that Democrats from states with biopharmaceutical companies were willing to join with Republicans in supporting changes in FDA’s laws and actions. The current effort makes clear that medical device companies are capable of bringing together a similar coalition.

I recommend keeping an eye out for further developments in medical device reform. The lessons learned may well affect your own interests.


When Abbreviated May Not Mean Faster or Easier    July 25th, 2010

FDA is working on an approval pathway for bio-similars, re-examining the way medical devices are reviewed, trying to upgrade the quality and speed of generic drug reviews and will soon be evaluating its process for granting accelerated approvals to drugs. These seemingly unconnected activities all have in common that they are supposed to be abbreviated processes to get new products to patients more quickly without risking safety or quality problems. 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 »

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