5 Screw Ups That Will Delay Your FDA 510(K) Approval

5 Screw Ups That Will Delay Your FDA 510(K) Approval

May 12th, 2013 // 11:07 pm @

Latest FDA and cGMP Compliance News

In 2011, FDA did a careful analysis of all 510(k) data to figure out what was causing medical device review times to increase. In this study, FDA found six problems related to the quality of 510(k) submissions. If your application has any of these problems, you are probably going to see a delay in your 510(k) approval.

  1. Poor medical device description. Every submission for a 510(k) has to have a full description of what the device is going to do. Without it, FDA cannot figure out if the device was evaluated by the sponsor right. If the reviewer is not able to tell from your submission what the device actually does, he can’t determine if the documents support the intended use of the medical device. So, you have to have a complete, clear description of what the device will do.
  2. Discrepancies in your submission. Discrepancies usually are related to the description of the device or use indications. Differences in the description of the medical device can have a big impact on device review. In a 510(k) submission, the intended use and the characteristics of the device will be compared to an earlier or predicate medical device. If the indications for use statement is not consistent in the various parts of the submission, FDA cannot figure out if the device has the same use indications as the predicate device. So any discrepancies will prevent a review of your medical device submission and you will need to clarify them.
  3. Indications for use problems. For the device to be found to be substantially equivalent, it has to have the same use indications as a device that is already marketed. Or, any differences between the new device and predicate can’t change the intended use. Also, the performance data that is needed to determine equivalence will depend upon the indications that are sought. So, a strong use indications statement is needed to see if the methods used to evaluate a medical device reflect the intended use. Some of the quality issues that are related to indications for use include poor ID of predicate for an indication, the indication has to have a PMA and a PMA has already been approved, and the use indication for a device that has a drug is not consistent with labeling.
  4. Not following current guidance or other standards. FDA comes out with guidances to help you see what you should include in your 510(k). If the device firm does not follow current guidances and does not explain why it did so, FDA would say the submission is poor quality and would send an AI letter that will quote the latest guidance so the company will get the needed information.
  5. Performance testing data is missing. You need to have performance testing for a traditional 510(k). Concerns with the testing adequacy can be related to the science involved. With no performance testing, FDA can’t determine if the device’s performance is the same as a predicate device.

 To learn more about how to submit your 510(k) successfully, be sure to review our upcoming Webinar on How to Bulletproof Your 510(K) Submission.


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