The FDA has committed to making the U.S. market a top priority for most developers of novel devices by the end of 2020. Today, many medical device companies target Europe first before setting their sights on FDA approval, thereby depriving U.S. patients of leading-edge products.
That situation reflects past FDA decisions about the amount of evidence needed to gain clearance to sell novel medical devices in the U.S. The agency has started trying to row back from these positions in recent years. And, with the current FDA commissioner aiming to accelerate development, this has now manifested in a near-term target.
“By Dec. 31, 2020, more than 50% of manufacturers of novel technologies for the U.S. market intend to bring their devices to the U.S. first or in parallel with other major markets,” the FDA’s device unit wrote in its 2018-2020 strategy document (PDF).
The wording of the text is significant. Rather than commit to being the first choice market for more than 50% of medical device developers by a certain date, the FDA has limited its task to ensuring that companies “intend” to prioritize the U.S. That reflects the fact it will take time for the FDA’s actions to change R&D priorities.
Device developers have already committed to R&D strategies for many products that will come to market between now and the end of 2020. The FDA is too late to influence these companies. What it can do is ensure that the U.S. is a top priority for companies that are yet to figure out their market access order. The intent of firms at the end of 2020 will show whether the FDA has hit this objective.
The FDA will work toward the 50% target in part by executing policies aimed at the three priorities detailed in its 2018-2020 strategy document. These task the FDA’s device center with improving employee engagement by 10 percentage points, streamlining 80% of its processes and forming 10 collaborative communities by the end of 2020.