On 1/22/2019, the FDA posted their final guidance describing the Safety and Performance Pathway option for 510(k) submissions. This pathway gives another option for medical devices that have technological differences but that are still as safe and effective as a legally marketed predicate device. Typically, in these situations, the new device manufacturer would have to make a direct comparison of the performance and technological characteristics to the predicate. The FDA determined that this approach may be more burdensome than the alternate approach outlined in the guidance.
Instead, for certain well understood devices for which there is a predicate, the new device manufacturer could show that their device meets performance criteria set by the FDA, rather than making a direct comparison to the predicate device. Meeting these criteria would allow the FDA to make a substantial equivalence determination to the predicate device. Depending on the type of performance criteria, a manufacturer may only need to submit a declaration of conformance. In other cases, methodology and data may need to be included. Of course, a manufacturer could still choose to use another 510(k) route and do a direct device comparison.
This sounds good, but there is a catch: the FDA has more work to do. The guidance goes on to explain that the FDA is planning to create a list of devices that are eligible for this Safety and Performance Pathway. The list will include device product codes, intended uses, and indications for use. The list will also include the applicable performance criteria that need to be met. Those criteria would be developed based on current legally marketed devices and will make use of FDA recognized consensus standards, FDA developed standards, guidance documents, and/or special controls.
Creation of the eligible device list will be an ongoing exercise, with new devices added as FDA expands reviews more and more devices. Additionally, performance criteria for existing devices may be changed, and devices could be removed from the list. In most cases, such changes to the list would only apply to new 510(k) submissions, unless a change was made due to safety reasons.
As of this moment, there are no identified devices. The FDA website describing this pathway states the following:
“The FDA expects to begin implementation of this pathway once the first device types and applicable performance criteria have been identified. Once the FDA begins to implement this pathway, a medical device manufacturer will be able to meet FDA-identified performance criteria to demonstrate that its device is as safe and effective as a predicate device.”
So, for now, the existing 510(k) pathways, traditional, abbreviated, and special are the way to go. However, current documentation on the FDA website, and other portions of the final guidance give us some hints as to which devices may be added to this list in the future. First, a search of the FDA’s recognized consensus standards database reveals over 1300 documents covering a wide range of topics. This shows that the FDA has a large existing database of standards it could use. Second, a search of the FDA guidance database for guidance issued by CDRH about medical devices and 510(k) yields over 130 hits. Although not all are related to 510(k) submissions for devices, a sampling of some hits on the first two pages includes: self-monitoring blood glucose systems for OTC use and prescription point of care use, peripheral vascular atherectomy devices, metal expandable biliary stents, and ultrasound systems and transducers.
There is no way to know for sure if these or other devices will end up on the eligible list, but existing consensus standards and guidance documents at least offer hints of where FDA could start. In the future, when devices are part of the list, what does a manufacturer need to do to take advantage of this pathway? The guidance document goes into more detail on that front. For a new device to be eligible for the pathway, it must be of a type on the eligible list, have a predicate device identified, and:
• The new device must not raise different questions of safety and effectiveness than the predicate
• The performance criteria must align with one or more legally marketed devices of the same type
• The new device must meet the specified performance criteria
• The new device must rely entirely on performance criteria to use this pathway
The release of the final guidance document on the Safety and Performance pathway for 510(k) submissions is definitely an important step in the FDA’s effort to modernize medical device regulations. However, work still needs to be done by the FDA before manufacturers can take advantage of the pathway. Until device types are identified, and performance criteria are established, the existing 510(k) pathways are still the way to go.
As evidence by this new released guidance, the medical device regulatory landscape is constantly changing. Globiox consultants pride themselves in staying up to date with these changes so that they can continue to provide the best advice to their medical device clients when preparing regulatory submissions for the FDA.
1. Safety and Performance Based Pathway. Guidance for Industry and Food and Drug Administration. Posted January 22, 2019. Retrieved from: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM604195.pdf?utm_campaign=Safety%20and%20Performance%20Based%20Pathway%20Guidance&utm_medium=email&utm_source=Eloqua
2. Framework for the Safety and Performance Based Pathway. Retrieved from: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm629679.htm
3. FDA Recognized Consensus Standards Database. Retrieved from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/results.cfm?start_search=21&sortcolumn=st&productcode=&category=&type=&title=&organization=&referencenumber=®ulationnumber=&recognitionnumber=&effectivedatefrom=&effectivedateto=&pagenum=10
4. FDA Guidance Database: Search for FDA Guidance Documents with CDRH, medical device, and 510(k) used in search criteria. Retrieved from: https://www.fda.gov/RegulatoryInformation/Guidances/default.htm