FDA Touts Major Improvements in Clinical Trial Approval Times for Medical Devices

Posted 23 January 2015 | By Alexander Gaffney, RAC 

FDA Touts Major Improvements in Clinical Trial Approval Times for Medical Devices

The US Food and Drug Administration's (FDA) medical device regulator, the Center for Devices and Radiological Health (CDRH), is touting huge improvements to the speed at which it is managing to approve new proposals to start research involving investigational medical devices.


The news, contained in a report issued by CDRH this week, focuses in part on the Investigational Device Exemption (IDE) process. An IDE is essentially a request to exempt a device from federal law, which otherwise prohibits a device from entering into interstate commerce without having first obtained marketing approval from FDA.

Once an IDE is approved by FDA, it allows the owner of the application to begin a clinical trial testing whether a device is safe and effective.

The problem, as FDA has conceded at various meetings, is that IDE applications can sometimes get bogged down as regulators request changes.

Starting in 2014, though, CDRH began working to "Expedite the safe initiation of clinical trials in the US."

Big Improvements

Those efforts are now starting to pay off. In its report, CDRH said that relative to 2013:

  • The number of IDE studies requiring more than two cycles to reach full approval in FY14 decreased by 34 percent.
  • The FY 2014 overall median time to full IDE approval decreased by 53 percent.

In addition, CDRH said it had succeeded in holding meetings with 100% of IDE applicants within 10 days during the last five months of fiscal year 2014. These meetings provide regulators an opportunity to identify potential deficiencies in an IDE application. If those meetings are happening soon after submission, that allows a company to quickly solve those problems.


CDRH Report

Categories: Regulatory News

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