mdi Consultants
Possible Major Changes to 510(k) Program
A 510(k) premarket submission is the most commonly used pathway to obtain an FDA market clearance for new medical devices. The essence of the 510(k) process is a demonstration of substantial equivalence (that is a device to be marketed is at least as safe and effective as a legally marketed device).
Over the years since its establishment in the Medical Device Amendments of 1976, the 510(k) program has evolved from a short review of device labelling, materials of construction, and design to a lengthy submission filled with voluminous test data and other supporting information to prove the substantial equivalence.
Last week, the FDA announced new steps to modernize the 510(k) clearance pathway. Previously, FDA made several attempts to modernize the 510(k) program including a major 510(k) programamendment in 1990.
The FDA has also taken steps to eliminate the use of 510(k) process for Class III devices and not a single Class III device was cleared via the 510(k) in 2018.
The FDA is now pushing for the use of more modern predicate devices. When new devices rely on older predicates, the FDA fears that they may not be accounting for the latest advances in technology that could benefit patients. Since 2012, the FDA has eliminated 1,477 devices as legal predicates in the 510(k) process. The FDA hopes that using predicates that are more modern would push for the continual improvement.
Older predicates could also not reflect the latest performance standards or the FDA’s most recent understanding of the benefits and risks associated with a certain type of device. In a statement released by FDA Commissioner Scott Gottlieb, M.D., the FDA plans to immediately begin making public information about cleared devices that had demonstrated substantial equivalence to older predicate devices that are more than 10 years old. The FDA will seek public feedbackregarding what actions to take to advance the use of modern predicates.
The FDA also announced plans to create an alternative 510(k) pathway, similar to the abbreviated 510(k) pathway, which allows substantial equivalence to be established by demonstrating that a device meets safety and performance criteria for a specific device type. The FDA believes that this would allow them to review products based on current standards and technology rather than comparing to previous predicate devices that are sometimes outdated. The full details of this plan have not yet been released.
As devices become more and more complex, it is important that the Agency keep pace with the latest standards, technology, cybersecurity, interoperability, biocompatibility, and usability. In addition to relying on more recent predicates, the FDA’s actions will also include closer examination of devices with documented safety issues that were initially cleared to market basedon older predicates. In the coming months, the FDA will be releasing more information about the use of older predicatesand other program changes.
From the combination of removing old predicates to getting rid of Class III 510(k)’s, it seems as if the FDA is pushing more devices towards a De Novo application process when seeking a marketing clearance.
What these changes will actually mean to the medical device industry and to get a 510(k) clearance is to be determined. For our client’s 510(k) applications that we have prepared or reviewed prior to submission, we have always recommended using the most recently cleared predicate, wherever possible. This makes it easier for the reviewer to search the predicate application in the FDA database. We would recommend that you always look to do this as well.
If your company has any questions regarding the new 510(k) program or you would like to discuss how mdi can assist with your 510(k) submission, feel free to send an inquiry email to [email protected] oruse our contact form</>. RE: 510(k).