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Regulatory Focus™ > News Articles > CDRH: New Pilot Seeks to Dramatically Speed up 510(k) Reviews Based on High Regulatory Quality

CDRH: New Pilot Seeks to Dramatically Speed up 510(k) Reviews Based on High Regulatory Quality

Posted 17 April 2012 | By Alexander Gaffney, RAC 

A new pilot program announced by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) aims to dramatically speed up 510(k) medical device reviews for manufacturers of certain in vitro diagnostic (ICD) and radiology products.

The announcement, made 17 April by Alberto Gutierrez, director of FDA's Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), claims the project, dubbed the "Triage" pilot, should get submission decisions back to manufacturers "sooner than expected."

True to its name, the Triage pilot program aims to focus resources into high-quality regulatory submissions that meet criteria for content and completeness.

"High-quality submissions that meet certain criteria and contain all of the information needed for a substantial equivalence evaluation will be slated for a 30-day Quick Review," writes Gutierrez. "Those 510(k) submissions not meeting these criteria would receive the standard review (generally 90 days) consistent with user fee performance goals."

Gutierrez lays out five criteria in his announcement for how regulatory professionals can see their submissions get through the Triage pilot program expeditiously:

  • be well-written, organized and contain all expected data and information to support substantial equivalence claims;
  • be for a device that is well-known to FDA;
  • be for a device that does not have existing or unresolved postmarket issues;
  • not require an extensive review by a subject matter expert other than the reviewer assigned to the submission; and
  • contain a 510(k) Summary, which is a summary of the information used to support the substantial equivalence determination.

Gutierrez takes pains to note the program will "preserve the quality and transparency of the normal 510(k) review process," only within a tighter, 30-day timeframe.

The Triage pilot will be re-evaluated within six months of the program's launch, and summary information will be posted online at that time, said Gutierrez.

Read more:

FDA - The Triage Pilot: Increasing Efficiencies for Device Review

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