Measuring the Current Regulatory Wind: FDA Commissioner Hamburg to Scrutinize 510(K) Process

New FDA Commissioner Dr. Margaret Hamburg noted in a WSJ interview that she sees the FDA as a "public health agency" — not a radical notion for the entity charged with regulating food and drugs in the U.S. However, by putting this imprimatur on the agency she has made it clear, especially in light of recent history in which some medical devices have received expedited — 510(K) — approval when some have argued more data was needed, she has put the medical device industry on notice that the agency has not adequately ensured public health and that the 510(K) process may be part of the problem.

Former FDA Commission David Kessler separately concluded that the FDA’s device group, the Center for Devices and Radiological Health (CDRH), was "dysfunctional" and "in meltdown" following a number of device approvals that took place over the objections of some FDA experts.  Critics have argued that the industry exerts too much influence over the FDA, resulting in approvals of products without adequate data, an argument given credibility by some high profile product failures such as ICD leads.

Regulation of medical devices should be expected to change over time, coinciding with  the rate at which new technologies emerge, the changing demands of industry, the sometimes fickle demand of healthcare users ("more safety" versus "more approvals") and the resulting political will of all involved to drive or resist change.

Of course, it is natural for a new FDA commissioner to take a de novo view of the agency and reset its mandate given the opportunity afforded a new leader.  Dr. Hamburg may well take a stance that is less compliant with the demands of industry by reining in the 510(K) process.  This should be welcome by the device industry, if it has a view above the immediate horizon, since a less supportive stance toward the regulatory process in today’s climate (the prospect of the Medical Device Safety act to counter Riegel v. Medtronic) is likely to result in even more restrictive control over the industry.

When an issue has as many stakeholders as does the regulation of medical devices, the only thing that can be certain about the wind blowing in one direction, like restricting 510(K) approvals, is that eventually the wind will blow in the other direction.


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