Regulatory Focus™ > News Articles > Shuren: Predicate Device 'Loophole' Must Be Closed

Shuren: Predicate Device 'Loophole' Must Be Closed

Posted 28 February 2012 | By Alexander Gaffney, RAC 

The head of the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is calling for the end to a so-called "loophole" in the 510(k) medical device approval pathway.

In remarks to Bloomberg News, CDRH Director Jeffery Shuren said that the agency needs new authority to reject new devices that are seeking approval based on being substantially equivalent to predicate devices that were subject to safety recalls.

The 510(k) application pathway is used by FDA to clear devices that it believes have already been proven to be safe based on a finding that they are "substantially equivalent" to an approved predicate device. This allows manufacturers that have created a new device based on a prior device's design to forgo clinical trials and access the market in an expeditious manner.

According to Shuren, "the FDA has to approve devices that cite an eligible predicate unless the older device has been ordered off the market by the agency or a court order."

Twenty-eight devices were found to be substantially equivalent to a predicate known to be subject to safety recalls in 2011.

Shuren's remarks come after a bill was introduced 31 January 2012 that would give the agency that exact authority.

The Safety of Untested and New Devices Act of 2012 (SOUND Devices Act), introduced by Rep. Ed Markey (D-MA), aims to "amend the Federal Food, Drug, and Cosmetic Act to ensure that a medical device is not marketed based on a determination that the device is substantially equivalent to a predicate device that has been recalled, corrected, or removed from the market because of an intrinsic flaw in technology or design that adversely affects safety, and for other purposes."

Read more:

Bloomberg - FDA Device Chief Says Approval 'Loophole' Needs Closing

Regulatory Focus - Duo of US Bills Aim to Prevent Drug Shortages, Amend 510(k) Pathway

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