In Major Victory for Industry, FDA says Existing 510(k) Guidance to Remain 'Mostly Unchanged'

Posted 26 February 2014 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has released the text of a congressionally mandated report outlining its plans for the future of its medical device premarket notification process-also known as the 510(k) clearance process-saying that it intends to largely leave its existing 1997 guidance document as-is.


In 2011, FDA released a new guidance document, 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device, meant to bring an update its 510(k) process, which had largely remained static since 1997.

But if the changes were meant to allay industry concerns, they wound up having the opposite effect. Numerous industry analysts noted that the 2011 guidance would significantly increase the number of required 510(k) applications, potentially creating a backlog of applications and further slowing the device regulatory process.

"The only thing that appears certain is that CDRH believes many more modifications necessitate a new 510(k) than had been the case," explained FDA Law Blog's Jennifer Newberger in a July 2011 post. "There are no changes where 510(k)s that were needed are no longer required, but there are many changes for which companies would have used a letter to file that would now need a 510(k)."

Industry's unrelenting criticism of the 2011 guidance eventually found its way before Congress, which at the time was considering reforms to FDA under the terms of the FDA Safety and Innovation Act (FDASIA). Legislators, already focused in on the medical device process due to other alleged problems, were receptive to that criticism, and in July 2012 voted to order FDA to withdraw the guidance under Section 510(n)(2)(B) of the law.

The agency was further ordered to entirely disregard the 2011 guidance document and not issue any other 510(k) guidance until it has briefed Congress in a report on its intent to issue new guidance. The 1997 guidance remains in effect until that time.


That report has now been published, with FDA largely acquiescing to congressional and industry concerns and stating that the 1997 guidance will remain as the "foundation" for future guidance and policy develop.

While acknowledging that patient and consumers groups have generally supported a more vigorous 510(k) notification system, FDA said that the 1997 guidance would stand largely as-is with the exception of "some small changes … to ensure clarity and consistency of interpretation."

"The Agency's analysis has shown that although there are certain areas of its 510(k) device modifications policy that should be updated or revised, the 1997 Guidance is a solid foundation and should remain mostly unchanged," FDA wrote.

Upcoming changes to the guidance will include "targeted revisions" meant to clarify key terms and explain the role of quality systems in deciding whether a 510(k) is necessary, FDA said. The "overarching policy framework" will remain "intact," FDA said.

Other proposed changes will include an "updated flowchart and additional appendices" meant to provide examples of device changes that do not require a 510(k), as well as device-specific recommendations.

Notably, FDA said it also intends to develop a separate guidance on changes to software, alleviating a major concern by industry that each update to a smartphone application or software would require a new 510(k) submission.


FDA's 510(k) Report

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