Device Firms Snub Electronic Filing, Survey Finds

Lawrence Lloyd

October 1, 2008

2 Min Read
Device Firms Snub Electronic Filing, Survey Finds


Electronic 510(k) Submissions by the Numbers

84percentage of firms that have never filed electronically

8percentage of firms that believed electronic filing made submission easier

4percentage of firms that thought FDA's automated tools were too hard to use

A 510(k) benchmarking survey on submission and clearance practices found that even as FDA transitions to electronic filing, most device firms have not relinquished paper-based systems.

The survey, conducted jointly by Compliance-Alliance LLC and Certified Compliance Solutions, found that an overwhelming majority (84%) had never filed a 510(k) submission electronically. Half the respondents who had used FDA's automatic tools for electronic 510(k) submissions said that the tools made submission easier, while the other half said the tools made filing more complicated. Among the survey's findings are the following:

  • Most companies received clearance in 120 days or less.

  • Most firms do not use a third-party reviewer for 510(k) submissions.

  • FDA requests additional data for at least 89% of submissions.

  • The majority of companies submit five or fewer 510(k)s annually.

Some companies do not market products subject to 510(k). But 31% of those respondents intended to use the cleared product as a predicate for a future submission.

In comparison with clearance methods used by other countries, 62% of respondents thought the FDA 510(k) process was more complex, but most said it also was appropriate to ensure safety. Firms generally thought that the agency's review and the questions therein were appropriate. About one-third of respondents either thought that FDA asked for information beyond what is required or asked questions that were beyond the scope of equivalence.

In submitting a new 510(k) for a device modification, about two-thirds of respondents cited change in the indications for use as the primary reason. The other most common reason was evolution of the device's functionality.

Conducted in June 2008, the survey had 235 respondents representing a variety of large, medium, and small device firms. For more information about the survey, visit

Copyright ©2008 Medical Device & Diagnostic Industry

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