A Newly Candid FDA on the Future Of Medical Device Regulation

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be willing to risk putting money to back the development of specific devices. In the medical device industry so many of these companies are small businesses that need to find sources of funding in order to drive their R&D, unlike the bigger companies which are able to generate that funding based upon sales of products they already have in the market.

SW: Do you think it’s going to be doable to offer industry more predictability? Does it boil down to clearer guidance, or more frequent dialogue between reviewers and each of the companies? How do you think you fix that problem?

JS: First of all yes, I think it is doable. Guidance for individual kinds of devices is one piece of it but there is a lot more that we need to be looking at in terms of how we actually run the pre-market review programs, particularly the 510k program, and how we provide input and expertise in the development of clinical trial protocols in support of the few 510ks that need clinical data.

Science constantly changes and our understanding of the risk/benefit profile of a device changes overtime. Sometimes, with greater experience and more data we realize that the device is safer than we originally thought. and you can imagine then we may need less information for a similar device coming in the door. In other cases we learn of a new safety problem and now our expectations for what a manufacturer would have to submit to us to demonstrate their device is safe and effective is going to change, because they’re going to need to address this new safety concern. What’s essential here is that when we recognize that the science has changed, and our regulatory expectations need to change accordingly, how can we communicate that to industry in a legally permissible manner that gives them as much advanced notice as possible? The way it’s done today is either a one-off ad-hoc approach, where a manufacturer learns about [the new issue] when they come in to see us—they may be coming in with their submission and we say “Well this was good before, but its not good anymore,”—or we could put out guidance. But the challenge with guidance is that it’s a very time-consuming process to develop, issue, get comment on, and finalize a guidance document. So we are exploring other options. All of these issues we’re going to be talking about in two reports that we’re hoping to release in the next few weeks. One is specifically on the 510k program and the second is on the use of science in regulatory decision making.

SW: And just to make sure, the one thing you’ve made clear is that the 510k process it going to stay, right?

JS: That’s right, the one thing I can say is that … 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!