It’s been quite a year: COVID-19, a change in administration and a year of transition for FDA digital health policy. In light of all the change and uncertainty, many digital health companies are struggling to decide upon a regulatory strategy for 2021.
My advice? If at all possible, stay away from FDA. They have enough to do right now. The people I know at FDA have been working 12- and 15-hour days most of the year. They’ve been doing incredible work, both on the review side and the policy side, when it comes to COVID-19. In fact, if you haven’t already done so, I would recommend that you send anyone you know at FDA a holiday card. And thank them for their service.
But back to business. You need to stay away from FDA if you can. We need to confront reality. Here are three reasons why you should try to stay away.
1. There is no benefit to being FDA regulated if you can avoid it
As a preliminary matter, let me explain what I mean by “if you can avoid it.” Everyone knows the difference between tax evasion and tax avoidance. Tax evasion is lying about something in order to avoid paying tax. Tax avoidance is prudent planning, for example, to fund a Roth IRA. I am advocating FDA avoidance, not FDA evasion.
FDA’s regulation fundamentally revolves around claims made about products. Typically, for huge number of digital products, there are claims FDA would not regulate and there are claims FDA would. I’m strongly recommending that you consider limiting yourself to making unregulated claims for the near future.
The path to regulatory authorization for many digital health products is long, unpredictable and expensive
Let’s look at the data through September 30, the end of the government’s fiscal year 2020.
Novel technologies, and those include many of the new digital health products, are not eligible for pre-market notification because there is no predicate device already on the market. As a consequence, such products must be submitted in a de novo application.
But the de novo process is not a place you want to go. It is highly unpredictable for the simple reason that there are neither guidance documents nor a general path to follow specifically for the new device.
FDA gets to examine the device’s fundamental safety and effectiveness, as opposed to substantial equivalence, so FDA asks many wide-ranging questions. Also, clinical trials are typically required, and those trials are costly.
That means the process is also uncertain from an outcome standpoint. Consider this data on the chances of success with a de novo submission.
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