The Challenge of FDA Clearance

As I’ve talked to 100s of companies creating devices for healthcare, there’s inevitably the question: “Are you FDA cleared?” There answer usually tells me a lot about the company and what their goals are for the product. Generally, it’s a question of if they’re going to go after the consumer space (ie. no FDA clearance) or after the medical market (ie. FDA clearance preferred).

In a few cases, I’ve talked to companies like EarlySense that have an FDA cleared product for hospital beds and a non-FDA cleared product for consumers. It was interesting to hear the reasons why they chose to release a non-FDA cleared product for consumers since they already knew they had the capability to go through the FDA clearance process. Their answer to me was instructive.

The core of their response was that FDA clearance is not a one time event and so this limits their ability to iterate and release product updates.

For anyone working in the startup world, it runs completely counter to the startup culture. The idea of iterating quickly and often is part of the mantra of most startup companies in silicon valley and now around the world. The FDA’s clearance process runs almost completely counter to this idea.

With this type of restriction, it makes sense why so many companies would avoid FDA clearance and just create a direct to consumer product that doesn’t require FDA clearance. The ongoing FDA clearance requirements can be a bear. What company wouldn’t want to bypass it and just iterate as they please?

The challenge with this approach is that there are reasons that FDA clearance is so challenging. First, it searches to provide a level of safety as far as what’s being implemented and the results of the device actually being tested and confirmed. Second, it creates a trust that most doctors (and their malpractice and insurance companies) want to see before using it.

Certainly, we could argue about how effective the FDA clearance is about ensuring safety and results, but that’s a topic for another day. If nothing else, it requires many organizations to think deeply about what the safety of the patients that are impacted by the device and consider the promises they make to customers. Those are two things that are missing in my consumer health devices and apps.

It’s a tough balance and I don’t think we’ve fully figured it out. How do you ensure safety and efficacy while still allowing the entrepreneurial spirit of innovation to thrive?

About the author

John Lynn

John Lynn

John Lynn is the Founder of, a network of leading Healthcare IT resources. The flagship blog, Healthcare IT Today, contains over 13,000 articles with over half of the articles written by John. These EMR and Healthcare IT related articles have been viewed over 20 million times.

John manages Healthcare IT Central, the leading career Health IT job board. He also organizes the first of its kind conference and community focused on healthcare marketing, Healthcare and IT Marketing Conference, and a healthcare IT conference,, focused on practical healthcare IT innovation. John is an advisor to multiple healthcare IT companies. John is highly involved in social media, and in addition to his blogs can be found on Twitter: @techguy.