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Senators Introduce Bipartisan Legislation to Streamline Medical Approval Process

Thursday, October 22, 2015  
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Senators Introduce Bipartisan Legislation to

Streamline Medical Approval Process

Senators Cory Gardner (CO) and Joe Donnelly (IN) recently introduced the "Rare Device Innovation Act" and the "FDA Regulatory Efficiency Act," two bills which intend to streamline the U.S. Food and Drug Administration (FDA) approval process for certain medical devices.

The Rare Device Innovation Act expands an existing program which simplifies and expedites FDA approval of medical devices that treat rare diseases such as ALS, cerebral palsy or Hodgkin's lymphoma. Currently, FDA has a simplified approval process for devices that treat rare diseases that affect 4,000 patients or fewer. The Rare Device Innovation Act increases the threshold from 4,000 to 8,000 patient cases for medical devices that will qualify for expedited and simplified approval.


The FDA Regulatory Efficiency Act provides the FDA with the authority to transfer the initial review of 510(k) medical devices to accredited third parties that apply for approval through the FDA. By shifting the review process of certain devices to accredited third parties, the legislation intends to give FDA more time reviewing new breakthrough technologies, expediting them to the market for patients in need. To read more on these bills, please click here.