Six Mistakes Sure to Delay Your FDA 510k Submission

See all US medical device consulting services.

In July 2011, the US Food and Drug Administration conducted an analysis of its 510(k) data to determine the causes of increasing medical device clearance review times. In the study, the FDA identified six deficiency categories of what it considers "quality" issues with 510(k) submissions. Those deficiencies are listed below. If your 510(k) application contains any one of these issues, your medical device 510(k) review will likely be delayed in being cleared by FDA.

1. Inadequate device description - Every 510(k) submission is required to have a description of what the device is intended to do. Without this description, the [FDA] reviewer cannot determine if the device has been evaluated properly by the sponsor. In other words, if the reviewer can’t tell from the submission what the device does, he or she cannot determine if the documentation included in the submission supports the device’s intended use. Therefore, it is essential that a thorough and clear description of the device be provided. Without it, a substantive review of the submission cannot be performed.
2. Discrepancies throughout submission - Discrepancies in this category most often related to device description or indications for use. Differences in device description can have a substantial impact on the review of a device because, under the 510(k) pathway, the intended use and technological characteristics of the new device are compared to that of a predicate device. And, when the indications for use statement is inconsistent in different parts of a submission (e.g., cover letter, indications for use form, 510(k) summary, device labeling have a different indications for use statement), we [FDA] cannot determine if the device has the same indications for use as a predicate or if any differences alter the intended therapeutic/diagnostic effect of the device when compared to the predicate. Therefore, discrepancies preclude substantive review of a submission and require clarification.
3. Problems with indications for use - In order to be found substantially equivalent, a device must either have the same indications for use as a device already on the market (“predicate” device), or any differences in the indications for use between the device and the predicate must not alter the intended use (i.e., the device’s intended therapeutic/diagnostic effect). Furthermore, the type of performance data necessary to assess equivalence is dependent upon the indications sought. Therefore, a clear indications for use statement is necessary to determine if the methods used to evaluate the device accurately reflect its intended use. Quality issues related to indications for use include: lack of identification of any predicate for the indication, the indication requires a Premarket Approval (PMA) and for which a PMA already has been approved, the indication for use for a device that uses a drug is inconsistent with the drug labeling.
4. Failure to follow or otherwise address current guidance document(s) or recognized standards - FDA issues guidance documents or recognizes a national or international standard to help manufacturers determine what information to include in a 510(k) submission generally and for certain device types specifically. If a manufacturer fails to follow current guidance (i.e. that which is up-to-date) for a certain device type or a recognized standard, and offers no explanation for its failure to do so, FDA would consider that submission to be of poor quality and would issue an AI Letter that quotes current guidance to obtain the missing information. For our [FDA] analysis we only determined that a submission had this deficiency if the AI Letter cited or quoted a guidance document.
5. Performance testing required for certain device types is completely missing (i.e., no performance data provided at all) - Performance testing is required for all traditional 510(k)s. Because concerns with the adequacy of the testing provided in 510(k) submissions can pertain to the adequacy of the science, for our [FDA] analysis, we only determined that a submission had this deficiency if no performance testing information was provided at all. Without performance testing, we [FDA] cannot evaluate whether a device’s performance is substantially equivalent to that of a predicate.
6. Clinical data required for certain device types is completely missing (i.e., no clinical data provided at all) - For some device types, FDA requires clinical performance data to demonstrate substantial equivalence. FDA considers a submission to be of poor quality when such testing is clearly outlined in a device-specific guidance document or in a pre-IDE, but is completely omitted from a 510(k) submission. We [FDA] did not consider it a deficiency if some clinical data, though inadequate, was provided.

The full July 2011 FDA study on 510(k) review times provides a wealth of additional insight as to why 510(k) submissions are delayed based on historical data analyzed by FDA. You can also see read the Emergo Group analysis of FDA 510(k) review data from 2006-2010 we performed in June 2011.

Please contact us for more information on obtaining US FDA 510(k) clearance for your medical device.