FDA’s Latest Advice for Strategic Considerations for 510K Applications
(Thursday, September 7, 2023)
510k constitutes both the most common kind of device market approval applications and the most controversial ones due to predicate creep, need or not of clinical trials, and the amount of supporting information needed for clearance by the FDA. These very critical strategic considerations could vastly affect the time needed for the creation of a reasonable 510k application and the review outcome. The FDA released three new Guidance Documents this week to help developers with these strategic issues and help design a suitable development plan for 510k devices. These guidance documents also provide insight into the internal review process for these applications at the FDA.
One of the first strategic considerations for a 510k device is the selection of a suitable predicate device. The FDA guidance on predicate device selection describes the rationale for the selection of a suitable predicate device from among several available, if applicable, or a predicate device approved more than 10 years ago. Predicate device(s) approved less than 10 years ago may have test data from current methodologies and may be more suitable compared to devices cleared a longer time ago. Older devices may still be the preferred predicate if there is significant safety and user experience data available. In general, FDA recommends selecting predicates with higher safety and performance data, with a better understanding of risks and the related mitigation strategies, and ones that are not associated with a design-related recall.
The second critical consideration in 510k device development is whether clinical trials are needed for performance evaluation. The new FDA guidance describes scenarios where clinical trials are likely needed to support a new 510k application. Clinical trials may be needed for the new device if there are significant differences between the indications for use or intended use between the new device and the predicate such as differences in patient populations, disease, anatomical site, and different benefit-risk profile. Other factors that may necessitate clinical testing data are significant differences in the technological characteristics such as material, design, energy source, or other device features between the new device and the predicate device. New devices where the significant equivalence cannot be determined without clinical trials will obviously require clinical trials as would new devices posing a new or increased risk compared to the predicate device.
The third guidance discusses clinical trials for implanted devices. Generally, most implanted 510k devices will likely require clinical trials along with a vigorous multi-dimensional non-clinical testing program that may even include animal testing.
The FDA has been working to modernize and improvise the 510k application process for the last few years. However, most FDA guidance documents so far have been procedural in nature. This set of three complementary guidance documents goes further by describing strategic considerations for 510k development programs. Most 510k programs requiring clinical trials will also be eligible for pre-submission discussions with the FDA to discuss the design of the clinical trial protocols prior to initiation of the trial and to discuss the results of the clinical trials prior to submission of the trial reports in the application. Overall, a great read for anyone working on a new 510k device program.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC