The FDA is moving forward with its commitment to strengthen and modernize the 510(k) program. The Safety and Performance Based Pathway is designed to provide a direct and transparent approach to demonstrating safety and effectiveness of low to moderate risk devices that can meet FDA-identified performance criteria to demonstrate substantial equivalence.
Background information on the Safety and Performance Based Pathway and guidance documents can be found here.
Below is a summary of the nuances that FDA wants your organization to consider if you are in the process of submitting a 510(k) or are considering submitting a 510(k) for well-understood Class II devices through the new Safety and Performance Pathway for Certain Device Types.
First, manufacturers must determine if the device is appropriate for the pathway. The scope of each device-specific performance criteria guidance identifies device types that are appropriate. The guidance indicates which performance device-specific criteria need to be meet, and all criteria outlined must be met.
Secondly, it is still necessary to identify an appropriate predicate for your submission, even though it is not necessary to conduct side by side performance testing of the subject test to the predicate device.
Third, new submissions through the Safety and Performance pathway are evaluated through the same 510(k) substantial equivalence decision flowchart as before. What is unique about this pathway is that to demonstrate performance the subject device must meet all of the FDA identified criteria listed in the device specific guidance. FDA believes this is important as criteria to appropriately determine substantial equivalence “when the indications for use and technological characteristics do not raise different questions of safety and effectiveness from that of the predicate device. And, that the criteria align with one or more predicates of the same device type.”
Key Points to Consider When Submitting a 510(k) to the Safety and Performance Pathway:
The Safety and Performance pathway will have a Medical Device User Fee Amendment (MDUFA) review clock of 90 days, similar to the traditional and abbreviated pathways.
The MDUFA user fee is the same as other 510(k) submissions.
Manufacturers should identify that their submission is intended for the Safety and Performance pathway to allow FDA to adequately process the submission in the system.
The Refuse to Accept process (RTA) is consistent with the RTA policy guidance and is similar to the abbreviated 510(k) RTA checklist.
The timeframes for RTA and substantive interaction is the same as other 510(k)s.
There is an opportunity for 510(k)s submitted to the Safety and Performance pathway to be converted if there are issues that preclude review through this pathway.
What if the device does not meet the Safety and Performance pathway criteria after submission?
The determination for whether a device is appropriate of the Safety and Performance 510(k) pathway is typically made during the RTA review stage. During the RTA review stage, if the submission does not have sufficient information or does not meet the criteria there is an opportunity for conversion to another viable 510(k) pathway. However, the conversion may necessitate additional testing that includes a predicate device.
Take Advantage of the Pre-submission or Q-Submission (Q-Sub) process to get further clarification as to whether your device is appropriate for any of the 510(k) pathways.
The FDA offers Q-Sub as an opportunity for manufacturers to obtain FDA feedback prior to an intended submission. These meetings are voluntary but can provide valuable insights for manufacturers on both potential and planned medical devices, as well as biologics and drug submissions. The Q-sub meetings are a great avenue to ask FDA questions, gain valuable feedback, and get a documented formal response that can be of future use.
The Q-Sub process can also be used which test methods outside those recommended by FDA are appropriate to meet the identified performance criteria.
Additionally, Q-Sub can be used if additional testing that your organization identified outside of the guidance is necessary to demonstrate the devices safety and performance on a case-by-case basis. The example FDA provided regards adding language to labeling in cases where performance testing is not included in the device-specific guidance. Under this circumstance, additional testing is required.
FDA Encourages Manufacturers to Be Involved
All stakeholders are encouraged to submit comments during the public commenting period on the device-specific performance criteria draft guidance.
The docket for safety and performance guidance will remain open for suggestions, and it is regularly monitored.
FDA also included a list of the following resources:
Need Expert Medical Writers for Submission Support?
Getting these technical documents together for any 510(k) submission takes expertise and time. Criterion Edge has experience medical writers that can provide support developing and producing your devices 510(k) submissions or pre-submissions. Please reach out to us for a free consult.
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