Recently the FDA released an announcement outlining plans to further modernize the 510(k) clearance pathway. This briefing falls in line with the latest efforts by the FDA to promote and improve safety and effectiveness in an efficient manner. The current 510(k) framework, which has been in existence since the 1976 Medical Device Amendments will undergo some much-needed updates in the near future to adapt to the ever-evolving medical device landscape. The FDA has already taken steps this past year to begin the transformation process, including the release of a draft guidance regarding the abbreviated 510(k) program. Additionally, the agency recently shared a “performance report” describing various measures implemented in the last 10 years to improve the 510(k) pathway, with a spotlight on recent efforts. These actions taken by the FDA include:
Increasing premarket expectations for 510(k) submissions. The release of several device-specific guidance documents and policies over the past decade has raised the bar in regards to submission content expectations. This increase in transparency of what is expected has resulted in a 150% increase in the length of 510(k) submissions since 2009.
Implementing a “Refuse-to-Accept” policy to improve quality of submissions. The FDA’s “Refuse-to-Accept Policy” ensures that submissions will not be accepted for review unless 52 specific submission elements are present and complete. This has not only improved the overall quality of submissions but has also increased the efficiency of FDA review process, ensuring that valuable time is not spent reviewing incomplete applications.
Improving consistency and thoroughness of 510(k) review. FDA staff has increased the time spent reviewing each submission by 32% in the last decade and has also initiated the use of a SMART memo template which has guided device reviewers towards increased consistency.
Moving towards eliminating the use of 510(k) for Class III devices. As recent as 2009, there were still 25 Class III device types which had been on the market prior to the 1976 Medical Device Amendments, that were still eligible for the 510 (k) process. The FDA has worked to remedy this situation in two ways. One includes releasing specific final rules and orders that require submissions of a Premarket Approval application for some of these devices. The other method is appropriately down-classifying some of the devices to Class I or Class II. As a result, in 2018, there were zero Class III devices cleared for marketing through the 510 (k) pathway.
Eliminating the use of more than 1000 510(k)s as legal predicates. The FDA has worked to discontinue the use of a 510 (k) cleared device as a predicate when it raises safety concerns. In some cases, devices can be up-classified such as from a Class II to a Class III when it becomes evident that the device should be regulated as high-risk. Since 2012, the FDA has eliminated the use of 1477 previously cleared devices as legal predicates.
So what is on the horizon?
Encouraging the use of more modern predicates. FDA Commissioner Scott Gottlieb has recently emphasized that “the most impactful way that we can promote innovation and improved safety in the 510(k) program is to drive innovators toward reliance on more modern predicate devices or objective performance criteria when they seek to bring new devices to patients.” The FDA plans to develop a proposal to potentially “sunset” older predicates and is also considering publishing a list of devices cleared using predicates that are more than 10 years old. The reasoning behind this is that when conducting comparative testing on new devices, the benefits and risks of more modern technology should be taken into account and older predicates might not closely replicate the new technology embedded in modern devices. As technology continues to advance new devices have the potential to become more interconnected, smaller and more portable, and incorporate advanced materials and processes such as mechanization and robotics. It will be interesting to see how this scenario unfolds, as changes to this process will undoubtedly affect various stakeholders.
New final guidance document: Alternative 510(k) Pathway. The FDA plans to issue a final guidance document to establish an alternative 510(k) pathway for “well-understood” devices. The proposed “Safety and Performance Based Pathway” would enable manufacturers to demonstrate substantial equivalence by using objective safety and performance criteria and it would remove the need for manufacturers to compare the safety and performance of their new devices to a specific predicate device, which may be decades old. The hope here is that this will alleviate some of the challenges of demonstrating equivalence between inventive new devices and older predicate devices that may contain outdated technology.
As the FDA continues to update and reform policies to keep pace with the ever-changing world of medical device advancement, one thing is certain, change is on the horizon. What are your thoughts on the future directions of the 510(k) clearance pathway?