FDA update – June 16, 2011

Initial Results of 510(k) Audit Analysis of Not Substantially Equivalent (NSE) Determinations:

Initial Results of 510(k) Audit Analysis of Not Substantially Equivalent (NSE) Determinations:

As a part of the 510(k) Action Plan published in January 2011, the Center for Devices and Radiological Health (CDRH) is committed to post initial results of an audit of the 510(k) program to the FDA website. CDRH performed this analysis to better understand the reasons that 510(k) submissions result in NSE determinations

For manufacturers, an NSE determination represents an inefficient use of time and resources. For FDA, NSE determinations require significant agency resources and time, yet fail to result in the marketing of a new product.

CDRH analysis of NSE decisions from 2005 to 2010 showed four main reasons why 510(k) submissions result in NSE determinations:

  • No Predicate -  a suitable predicate does not exist;
  • New Intended Use - the intended use of the new device is different than the intended use of the predicate;
  • New Technology - the technology is not substantially equivalent to the existing technology for the predicate; and
  • Lack of Performance Data - there were no 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.

The data shows that approximately 80 percent of NSE determinations are due to insufficient performance data because:

  • The sponsor failed to provide data or the data provided were inadequate;
  • Additional data were required due to a new indication, new technology, or a new safety concern; and/or
  • The demonstrated performance of the device was inferior to the predicate.

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 percent 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.


Although NSE determinations represent a small percentage of all 510(k) decisions, they utilize a greater amount of FDA time and resources than the average 510(k). The absence of a predicate, the introduction of a new intended use, or new technologies account for a minority of NSE determinations. The vast majority of NSE decisions are due to the absence of adequate performance data, sometimes despite repeated FDA requests.

For more information on this Document you can go to the following link: http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM259187.pdfor contact mdi at info@mdiconsultants.com REF: Analysis of NSE.