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Compliance In Focus
Posted by John Lehmann on Tue, Dec 4, 2012

FDA Audit Results- 510(k) NSE Determination

FDA Audit ResultsIn order to better understand the CDRH’s review of submissions that were found to be Not Substantially Equivalent (NSE), FDA published on its website the initial results of 510(k) audit as part of the Action Plan implemented in January 2011. The determination of NSE not only is an inefficient use of FDA’s time and resources, but can also be a costly delay for industry. With this information and analysis now available, the goal is for sponsors to understand the reasons the NSE determination resulted, as well add some clarification to the process.

As stated in the report, FDA’s reason for NSE Determinations between the years of 2005-2010 included:

  • No Predicate Device- A suitable predicate does not exist
  • New Intended Use- The intended use of the new device is difference than the intended use of the predicate device
  • New Technology- The technology is not substantially equivalent to the existing technology for the predicate
  • Lack of Performance Data- There was not performance data provided in the 510(k) submission, the data provided were inadequate, or the data failed to demonstrate that device performance was at least equivalent to the identified predicate

Lack of performance data accounted for 80% of the NSE determinations. Knowing how to submit data is a challenge most face when submitting a 510(k). This continues to be an area of concern that has historically plagued device manufactures regarding whether or not clinical data is required, and if so, to what extent.

Since the lack of performance data was the most common issue, additional analyses were conducted which found:

  • “In the majority of NSE cases, FDA made repeated requests for data because 510(k) sponsors failed to provide the requested performance data.
    • Specifically, for 88%of submissions found to be NSE, additional review cycles were necessary either because the sponsor failed to fully address FDA's original questions or because the sponsor's response raised new safety concerns that they failed to resolve.”
  • “In 18% of the submissions, the FDA asked for performance data that had not been required for SE determination of the predicate device.
    • For example, the FDA may have requested additional biocompatibility testing when animal deaths occurred in a study’s test group, but not in the control group. The FDA may have requested additional preclinical testing when adverse event reports raised a new, specific safety issue associated with failure of a material used in the device. The FDA may also have requested clinical data upon identification of a safety concern in the pre‐clinical studies.”
  • “In 16% of submissions analyzed, the sponsor provided performance data that showed poorer performance than the predicate device”

Running a clinical study could be a monstrous undertaking for a company who historically has not had to produce clinical data for their 510(k) submissions. IMARC published a whitepaper that deals with just this issue. Take time to download and read the whitepaper and FDA’s audit results and feel free to contact us with any questions you may have, or share them below.

Photo Credit: Victor1558

Register for Imaging in Clinical Trials Webinar December 2012

Topics: FDA Audit, CDRH, 510(k)


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