New Senate Bill Would Change the Way FDA Regulates Devices

Regulatory NewsRegulatory News | 22 March 2016 |  By 

A new Senate bill introduced this week would, among other things, allow the US Food and Drug Administration (FDA) to no longer require premarket submissions for some low-risk Class I and II medical devices.

The bill, which is sponsored by Sens. Amy Klobuchar (D-MN) and Pat Roberts (R-KS), and supported by industry group AdvaMed, would also:

  • Require FDA to address within two months any changes proposed to an appropriate standard established by a nationally or internationally-recognized standard organization;
  • Require new training for FDA employees on those standards;
  • Ensure a more transparent process for classifying devices, including providing “adequate time for initial presentations by the person whose device is specifically the subject of such review”;
  • Explore the use of pilot projects to figure out how to better track devices in once they are marketed.

As far as giving FDA the authority to remove devices from the so-called reserved list of low-risk devices, the bill would fix a glitch in a previous law that said FDA could not remove devices from the list, according to a draft of the bill.

JC Scott, senior executive vice president, government affairs, for AdvaMed said in a statement: “FDA has made great strides in recent years to improve the efficiency, predictability and transparency of its medical technology review process. But we believe that more can be done so that FDA is operating at maximum effectiveness to ensure patients have timely access to medical innovations.”

The bill is one of more than ten new bills the Senate Health, Education, Labor & Pensions Committee is considering as it looks to provide companion legislation to the House-passed 21st Century Cures bill, which also included a number of alterations to the way FDA regulates devices.

Back in October, two other bills were introduced to expand the threshold by which FDA could approve medical devices that treat rare diseases, including ALS and cerebral palsy, and another bill to provide FDA with the authority to transfer the initial review of medical devices seeking approval via the 510(k) pathway to agency-accredited third parties. 



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