Common Challenges for Manufacturers Making 510(k) Submissions Next

Common Challenges for Manufacturers Making 510(k) Submissions

By Linda Chatwin

Time To Read 2 minutes

According to its own policy, the FDA has 90 days to review 510(k) submissions received directly from medical device manufacturers. However, that time limit can be extended in cases in which FDA reviewers determine that a submission is incomplete, or that additional information from a manufacturer is required. FDA data indicates that the agency requests additional data in connection with approximately 75 percent of all 510(k) submissions received.[i] As a result, the average review time for 510(k) applications received directly from device manufacturers is now more than 145 days, a nearly 50 percent increase in review time over the past decade.[ii]

While the reasons for delays in the review of 510(k) submissions are varied, the FDA has identified[iii] a number of common factors that typically result in extended review times, as follows:

Inadequate device description—Surprisingly, one of the leading factors resulting in 510(k) review delays is the absence of a complete and thorough description of what the medical device actually does. According to FDA data, approximately 50 percent of all 510(k) submissions failed to provide an adequate device description. Without detailed information of a device’s intended function, FDA reviewers cannot assess whether the remaining documentation accompanying the submission is sufficient for the purposes of the review.

Nearly one-third of 510(k) submissions received by the FDA provided inadequate information regarding device biocompatibility

Failure to identify suitable predicate devices—The success of the 510(k) review process is dependent on a manufacturer identifying similar medical devices that have previously been cleared by the FDA. Predicate devices must be carefully selected so that their key characteristics are comparable to those of the device being submitted for review. But nearly 40 percent of 510(k) submissions failed to identify a suitable predicate device.

Missing or inadequate performance testing—Performance testing is required for all 510(k) submissions. Yet more than half of all 510(k) submissions fail to provide performance test data, or submit performance test data that was inconclusive. Without performance testing, FDA reviewers cannot evaluate whether a medical device is as safe and effective as the predicate device.

Missing or inadequate clinical data—In addition to performance test data, the FDA also requires the submission of clinical data for some device types to support specific clinical claims of equivalence with a predicate device. At least one in 10 510(k) submissions failed to include required clinical data. In some cases, the need for clinical data is not apparent during preparation of the 510(k) submission.

Missing or inadequate biocompatibility information—Nearly one-third of 510(k) submissions received by the FDA provided inadequate information regarding device biocompatibility, or failed to provide any biocompatibility data at all.

Failure to follow device-specific standards and current FDA guidance— Regulatory requirements are almost as unique and distinct as the countries that enforce them.  Even if a device is approved in another region, FDA may require more or less data or submission information in a different format.  FDA frequently issues general and device-specific guidance documents to aid manufacturers in understanding its requirements. Nonetheless, approximately 40 percent of 510(k) submissions fail to reflect current FDA requirements or guidance.

In addition to these common factors, omitting any required information or documentation, regardless of the reason, will almost always result in a request for additional information from FDA reviewers, thereby extending the review process. The FDA also provides comprehensive and detailed instructions for preparing a complete 510(k) filing. Even seemingly inconsequential deviations from these instructions, such as failing to follow pagination requirements or the FDA’s eCopy guidelines, can provide a sufficient basis to reject a 510(k) submission after initial screening, delaying the advancement to the substantive review phase.

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[i] A detailed timeline of the FDA’s communication performance goals in connection with 510(k) applications is available at Web. 14 January 2014.
[ii] “Medical Device Pre-Market Programs: An Overview of FDA Actions,” U.S. Food and Drug Administration, November 12, 2011. Web. 20 December 2013.
[iii] Statistics quoted in this section are derived from “Analysis of Pre-Market Review Times Under the 510(k) Program,” U.S. Food and Drug Administration, Center for Devices and Radiological Health, November 9, 2011. Web. 20 December 2013.