510(k) is the FDA’s clearance pathway for introducing new low to moderate risk medical devices to market. On November 26th, the FDA proposed sweeping updates to this process.  So, what are these changes and why is this good news for new product developers?

New benchmarks

The 510(k) clearance pathway heavily relies on the use of similar or equivalent devices already on the market, also known as predicate devices.  There is currently little to no criteria regarding the age of predicate devices, meaning that developers may find themselves basing the performance and safety of their new product on a device that is 20 years old (or more).  

The proposed changes to the 510(k) pathway will include the retirement of older devices as predicates in order to stimulate innovation.  The FDA is concerned that the use of older predicates hinders advanced products from reaching the market as it is more difficult to integrate new innovations with old technology.

Encouraging the use of new technology

One of the main goals of the proposed 510(k) updates is to keep up with the torrid pace of technological evolution that can be utilized in medical devices.  Developers will be encouraged to integrate advances in material science, digital health, automation/robotics, and 3D printing into new devices while improving safety and performance standards.  The FDA has observed stagnant improvement in some categories of devices.

For example, a medical device using outdated technology may simply be miniaturized, providing minimal benefit to the patient.  Under the proposed 510(k)changes, developers will be encouraged to utilize technological advancements that improve safety, performance, or both and create new standards (and predicates) for the industry.  This strategy will ensure that every new generation of devices will allow users to observe significant improvements and encourage them to replace what they currently have. More importantly, patients will benefit from being treated with the most up to date equipment.  Simply put, the FDA is promoting innovation and innovation results in sales.

Efficient product introductions

The new 510(k) approach will tentatively be named the “Safety and Performance Based Pathway”.  The FDA intends to allow the developers of certain device types to use objective safety and performance standards to demonstrate substantial equivalence in an effort to efficiently replace older predicates with those that have modern advancements.  

The FDA’s premarket review would be based on a forward looking modern standard that can be updated in sequence with technological advancement. The intention is for this new pathway to replace the current method where product developers compare their new device technology to obsolete predicates.

As of early 2019, the FDA expects to have executed these changes to the 510(k) clearance pathway.  Is your firm ready to be a major player in medical device innovation?