FDA Rolls Out Aggressive 510(k) Revision Plan

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Under attack from consumers for being too lax and from industry for being too stringent, the FDA today unveiled its controversial and long-awaited 510(k) plan it hopes will improve the review process for “certain innovative, lower-risk medical devices.”

Like most government wonks, the agency focused on numbers from the start. Today’s plan contains not 24 or 26, but 25 specific actions it plans to take. Those include:

  • Clarifying when clinical data should be submitted in a premarket submission, guidance that will increase the efficiency and transparency of the review process,
  • Establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making.

An ambitious rollout plan is outlined here:

Publicly, most device industry groups are cautiously praising the FDA, with a few exceptions, such as AdvaMed’s Stanford University report. Privately, most device makers tell us FDA is going overboard and will stifle medical innovation.

Today’s actions will result in “a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly,” Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH), told reporters in a conference call this afternoon.

Before marketing most lower-risk medical products such as certain catheters or diagnostic imaging devices, manufacturers must provide the FDA with a premarket notification submission.

In September 2009, CDRH set up two internal working groups to address concerns relating to the premarket notification process — industry argued that the 510(k) process was unpredictable, inconsistent and opaque, while consumers and health care professionals argued that the review process wasn’t robust enough. At the same time, CDRH also asked the independent, nonprofit Institute of Medicine to study the program. That review is still underway.

Reported by Michael Causey – you can read his other posts here.

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