A Newly Candid FDA on the Future Of Medical Device Regulation

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we are not recommending that the 510k program be abolished. As for other recommendations, it’s premature to say because we’re still wrapping up the report.

SW: Give me the broad perspective of what your hopes are for your office and what you wish 5 years down the road to have accomplished.

JS: I think, first and foremost, it’s having a smarter FDA and taking what we call a balanced public health approach. Our mission says that we are to protect the public health and to promote the public health. In the past, much of that focus has been on the protection side. There’s more we need to do there, but we also have to recognize there is the promotion side—that on the one hand we have to assure that the devices patients get are safe and effective and we use our enforcement tools wisely, but on the other hand we need to promote public health by facilitating innovation and fostering a culture of quality and prevention among industry. It’s striking that balance that I would like to achieve both on a culture level for the center and in practice.

One of the realizations we have come to as a center is that we have a unique experience and expertise that’s not available to industry, the venture capital community, the healthcare community, and even many of our foreign regulators. We see every moderate- and high-risk device before it goes to market. We get proprietary data on devices that isn’t available to anyone else but the individual manufacturer, so the manufacturer knows what it knows about its product, but we know about their product and their competitors’ products and we know about similar products. Even many of the foreign regulators don’t review medical devices before they’re marketed; they have third parties who do it. The third parties see some devices, other third parties see other devices, and much of that information is kept with the third parties and not reviewed by the regulator. We don’t do that here in the US. We review everything ourselves and we look at all of it, and having that depth and breath of experience and expertise puts us in a place where we can give insights back to the manufacturers that can be helpful in addressing problems with existing devices and that can be used in developing the next generation of medical devices.

SW: Can you give me concrete examples of this new approach where you give insight to industry in a way that wasn’t done before?

JS: A great example of how we are doing business differently already is what we have done with external infusion pumps. We were seeing that the number of adverse event reports pertaining to these devices was going up—we were seeing many recalls, about 87 recalls over the past five years—so external infusion pumps as a group were in kind of the top ten devices for adverse events reports and the top ten devices for recalls. Of the adverse event reports that came to us, many of them, according to the manufacturer, were mistakes on the part of the doctors and the nurses. But when we drilled down deeper we found it really wasn’t their mistake, it was problems with the design of that device.

SW: What kinds of problems?

JS: One was in the interface between the pump and the person who uses the pump. For example, we found that the on/off button was right next to the button you push to start the infusion, so sometimes people spent all this time to program the infusion pump and then they hit the wrong button, so instead of hitting it to start they turned it off and then walked away. Another example we saw was … Next Page »

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Sylvia Pagán Westphal is Xconomy's life sciences columnist. You can reach her at swestphal@xconomy.com or you can follow her on Twitter at http://twitter.com/sylviawestphal. Visit http://www.xconomy.com/author/swestphal/ for Sylvia's full bio and disclosures. Follow @

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2 responses to “A Newly Candid FDA on the Future Of Medical Device Regulation”

  1. Ruthie says:

    The 510(k) process and the FDA have been broken from the start and will continue to fail as we see time and time again.
    As a part of the TMJ Implant Disaster the FDA and the 510(k) failed so many innocent people. In the end it is all about $$$$ and the rats that were experimented on by the cockroaches are left running on a wheel with no answers, protection, or help. Rats and cockroaches both survived the nuclear bomb…but will all have to face our maker in the end.
    The FDA and Congressional Hearings are a waste of tax payers time and money. How did the government fix the complaints of long waits at the post office??? They took the clocks off the walls!!! Quit wasting our time and money. True honor, integrity, and character are lost to the evil $…God help us all!