FDA and the Device Industry: Friends or Foes?

“An open foe may prove a curse, but a pretended friend is worse.” When the poet John Gay wrote these words in 1727, the idea of an administrative agency like the FDA was likely the furthest thing from his mind. That he is now being quoted in a blog post to discuss the relationship between medical device companies and their regulatory oversight body shows that some ideas really do have staying power.

There have been many articles (here, here, here, and here) and even some late night TV shows that make it sound like FDA and the device industry are the best of friends, clinical evidence requirements are low, risky devices stay on the market, and FDA cares more about helping industry than protecting the public. In this author’s experience, the opposite is often true: FDA is very risk averse, reviewers do not want to be responsible for approving or clearing a novel device without what essentially amounts to a guarantee of safety, 510(k) substantial equivalence requirements have grown exponentially over the years, and although, as indicated in a prior post, CDRH talks a good game about innovation, that alleged commitment to innovation is overshadowed by fear of being the signature on a submission for a device that causes harm.

So what is the truth? Are industry and FDA friends or foes? As is often the case, the truth is likely somewhere in the middle. Some companies have positive experiences with FDA, and that does not mean getting through the clearance or approval process quickly; it means feeling like the relationship is collaborative rather than adversarial, that FDA appreciates and understands the various shades of gray that are associated with bringing a medical device to market, and that the company understands the importance of protecting the health of the public when it launches its new product. This can, and often is, the outcome, benefitting the company, FDA, and most importantly, the public.

But sometimes, FDA seems to take on the sheen of a pretended friend, and John Gay was right in stating that this persona is far more dangerous than knowing from the start that someone is a foe. With a foe, you consider all the possible outcomes, you expect a challenging conversation, you come prepared for the worst and hope it’s not as bad as you thought it would be. With a pretended friend, you let your guard down. Maybe you talk too much, say things that you shouldn’t. You are not on guard, and you are not prepared. When this happens, it is a virtual guarantee that you will not get what you want.

This is not to say that companies should not pull out all the stops to improve relationships with their review teams and management within CDRH and other areas of the agency. If you have those connections, use them—and if you don’t have them, reach out to us, because we might. It is always helpful for the FDA team to see that the folks on the other side of the table really do share the same goals: for safe, effective, novel devices to get to market to benefit the public health. If you can come to the table seeing eye to eye, it may make getting to the end a lot easier.

If you can establish a positive working relationship with the review team, you may conclude that FDA is a friend. Never forget that looks can be deceiving. You should always assume FDA is a pretended friend, and come prepared.