Common mistakes that can delay FDA 510(k) reviews
As discussed, there are two places where the 510(k) process can come to a halt. The first is the RTA process: an RTA is used when a submission does not contain all of the required information - for example, if electrical safety test data is required, but was not submitted. This can result in a significant delay. The other major impact to the successful clearance of your 510(k) is the AI Letter. Common issues that may result in an AI include:
Inadequate device description
All 510(k) submissions must include accurate descriptions of how the device is intended to function. An incomplete or inaccurate description will prevent FDA reviewers from determining if your device has been properly evaluated; reviewers will also be unable to determine if your documentation supports your device’s intended use. You must include a thorough and accurate description of your device to ensure a substantive FDA review of your 510(k) submission. Many devices, particularly those containing electronics require a very thorough and detailed technical description of how the device operates. For some devices, these requirements may be defined in a Guidance Document.
Discrepancies throughout submission
510(k) submissions are highly redundant – the same information appears in multiple sections throughout the document. Repeating this information may assist the FDA when they divide the submission among various sub-reviewers. Nonetheless, it is important to be consistent in these redundant sections.
Assure the Indications for Use is exactly the same every time it appears in the submission. Even a small discrepancy can trigger a RTA letter. As previously mentioned, your device should have the exact same indications for use as your predicate device or any differences should be very minor.Without a consistent Indications for Use statement, FDA reviewers cannot determine if you used appropriate methods to evaluate your device’s performance to support your intended use claims. Additionally, assure the standards listed are consistent throughout the document, that the predicates listed are consistent, etc.
Product name
The product name is likely to occur a hundred times throughout the submission, so ensure it is consistent throughout the documentation.
Failure to follow or address guidance documents or standards
In order to help medical device manufacturers determine what to include in their 510(k) applications, the FDA issues guidance documents or defers to national or international standards. Failure to follow current guidance or meet relevant standards for your device, without explaining why in your 510(k) submission, often results in an AI from the FDA. As mentioned above, these guidance documents may not have been updated recently and the standards cited may no longer be current.
Inadequate or missing performance testing data
All traditional 510(k) submissions must include performance testing data. FDA reviewers cannot determine substantial equivalence between your device and its predicate device without performance testing.
Usability report
Usability reports are an issue when the testing was not conducted as described in the guidance document. The sample size may have been too small, testing may not have included the how user will select the device (for OTC), etc.
Risk Management
The consensus standard for risk management in the US is ISO 14971:2007. It requires a Risk Management Plan, a Risk Management Analysis, and a Risk Management Summary Report. The analysis is frequently a Failure Modes and Effect Analysis (FMEA) – but other tools are also acceptable – and must be submitted with the 510(k). Risk Analysis is a complex, time-consuming team activity. Allow plenty of time to complete this process and documentation before finalizing the 510(k) submission.
Missing clinical data and forms
For some device types, 510(k) submissions must include clinical performance data in order to evaluate substantial equivalence. If clinical data is submitted, there are forms that document if the investigator had any financial relationship with the sponsor, as well as the ClinicalTrials.gov form, are required. Note that if clinical data is not submitted, these forms are no longer required.
As discussed, there are two places where the 510(k) process can come to a halt. The first is the RTA process: an RTA is used when a submission does not contain all of the required information - for example, if electrical safety test data is required, but was not submitted. This can result in a significant delay. The other major impact to the successful clearance of your 510(k) is the AI Letter. Common issues that may result in an AI include:
Inadequate device description
All 510(k) submissions must include accurate descriptions of how the device is intended to function. An incomplete or inaccurate description will prevent FDA reviewers from determining if your device has been properly evaluated; reviewers will also be unable to determine if your documentation supports your device’s intended use. You must include a thorough and accurate description of your device to ensure a substantive FDA review of your 510(k) submission. Many devices, particularly those containing electronics require a very thorough and detailed technical description of how the device operates. For some devices, these requirements may be defined in a Guidance Document.
Discrepancies throughout submission
510(k) submissions are highly redundant – the same information appears in multiple sections throughout the document. Repeating this information may assist the FDA when they divide the submission among various sub-reviewers. Nonetheless, it is important to be consistent in these redundant sections.
Assure the Indications for Use is exactly the same every time it appears in the submission. Even a small discrepancy can trigger a RTA letter. As previously mentioned, your device should have the exact same indications for use as your predicate device or any differences should be very minor.Without a consistent Indications for Use statement, FDA reviewers cannot determine if you used appropriate methods to evaluate your device’s performance to support your intended use claims. Additionally, assure the standards listed are consistent throughout the document, that the predicates listed are consistent, etc.
Product name
The product name is likely to occur a hundred times throughout the submission, so ensure it is consistent throughout the documentation.
Failure to follow or address guidance documents or standards
In order to help medical device manufacturers determine what to include in their 510(k) applications, the FDA issues guidance documents or defers to national or international standards. Failure to follow current guidance or meet relevant standards for your device, without explaining why in your 510(k) submission, often results in an AI from the FDA. As mentioned above, these guidance documents may not have been updated recently and the standards cited may no longer be current.
Inadequate or missing performance testing data
All traditional 510(k) submissions must include performance testing data. FDA reviewers cannot determine substantial equivalence between your device and its predicate device without performance testing.
Usability report
Usability reports are an issue when the testing was not conducted as described in the guidance document. The sample size may have been too small, testing may not have included the how user will select the device (for OTC), etc.
Risk Management
The consensus standard for risk management in the US is ISO 14971:2007. It requires a Risk Management Plan, a Risk Management Analysis, and a Risk Management Summary Report. The analysis is frequently a Failure Modes and Effect Analysis (FMEA) – but other tools are also acceptable – and must be submitted with the 510(k). Risk Analysis is a complex, time-consuming team activity. Allow plenty of time to complete this process and documentation before finalizing the 510(k) submission.
Missing clinical data and forms
For some device types, 510(k) submissions must include clinical performance data in order to evaluate substantial equivalence. If clinical data is submitted, there are forms that document if the investigator had any financial relationship with the sponsor, as well as the ClinicalTrials.gov form, are required. Note that if clinical data is not submitted, these forms are no longer required.
