Commentary: Why FDA’s software precertification program may be bad for business

Epstein Becker & Green's Bradley Merrill Thompson says the FDA's much-touted program is riddled with unseen costs and unanswered questions.
By Bradley Merrill Thompson
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About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. The opinions in this piece are Thompson's and don't necessarily reflect the opinions of MobiHealthNews or HIMSS.

FDA’s concept of a precertification program for software has certainly caught the attention of senior management at many companies. I’m hearing stories of unbridled enthusiasm for the idea. I describe it as a “concept” because, of course, it hasn’t been created yet. A year and a half after floating the idea and more than a year since the formal, public drafting process began, FDA has only circulated very high level concept papers.
 
As companies wait for more details, for several reasons they need to be just a little bit cynical about what they’re hearing, and become more active in trying to shape what the program ultimately turns out to be in some very key dimensions that could make or break the program.
 
Reasons to be cynical
 
I try hard not to let my old age make me too cynical. But some skepticism is healthy. To understand why I am skeptical here, I would encourage you to search the Twittersphere, LinkedIn posts, and summaries of speeches reported in the trade press to see what FDA is publicly saying about the program. If you’ve been around FDA for a while, you will be amazed. In the more than 30 years I’ve been practicing medical device law, I have never seen anything like this. The agency is on a full throttle sales mission from the Commissioner on down trying to convince the entire world that this precertification program is the best thing since sliced bread.
 
Ask yourselves, why? Why would FDA be engaged in such a concerted and resource-intensive push that is more akin to launching a new line of tennis shoes than it is traditional policymaking?  Do you really think it’s because FDA wants to make business more profitable for medical device companies? If you do, I have a bridge in London I’d like to sell you. No, FDA stands to gain a lot from the precertification program, and you need to understand what they get in order to assess whether it’s a good deal for industry.
 
Beyond just the extraordinary promotion by FDA, industry also needs to understand that there is a method to the agency’s sales process. Any salesman will recognize it. I was reminded of it in May when I was negotiating the purchase of a rug in Egypt. The salesman wanted to talk with my wife and me about all the different rugs they had, and work with us to narrow it down as to whether the rug was to be wool or silk, large or small, the type of pattern and so forth. When I repeatedly asked during that process about the price of the various options, he repeatedly deferred me, saying that he would have to talk to his manager and that we would surely work that out at the end.

When selling, you never lead with the price. First you get your customer to fall in love with the product, and then you present the price. Industry has not yet heard the price of the precertification program.
 
Selling points
 
So FDA started the development of its precertification program with the selling points, and has everyone in industry excited primarily about three potential benefits:
 

  1. FDA has said that it will review fewer initial launches of new software products. Exactly which ones will be reviewed and which ones will not has not been shared with the public. But they’ve told us it will be great and we will love it.
     
  2. FDA has said that for the products they will review, the review will cover fewer topics. They haven’t said how many fewer, or how much quicker the review will be, but they have told us it will be great and we will love it.
     
  3. FDA has said that they will review fewer changes to marketed software medical devices. They haven’t said which changes they will review and which ones they won’t, but they have told us it will be great and we will love it.

 
Pretty exciting stuff, in theory. Well over a year into the drafting process, we just don’t know what FDA will do or how much better it will be.