Choking off software competition is FDA Approved

Just in case you missed it, if you are a software driven device start-up, the FDA is about to give your established, competition a big leg up.

The new "Digital Health Innovation Action Plan" coming out of FDA's Center for Devices and Radiological Health (CDRH) has three key components, at least one of which, I predict, will be the equivalent of getting rid of "Net Neutrality"- favoring the big and established over the small and new.

The three components are:

1) More guidance addressing the 21st Century Cures act

2) Expanding US regulatory expertise regarding digital health technologies

3) FDA "Pre-Cert for software" a pilot program by which software companies, not software products get pre-approved. This is the problem child in my opinion.

The FDA presentation states: "The first step is a pilot program to develop a new approach toward regulating this technology – by looking first at the software developer or digital health technology developer, not the product." 

While this approach may seem efficient and benign, imagine the advantage a "Pre-Cert" company will now have over a new company. How much harder will it be for start-ups to penetrate manufacturers and capital markets in healthcare? Further, I will bet that post pilot, there will be user fees, re-certification fees, and more fees associated with this approach creating barriers for less well financed endeavors.

Of equal concern is the assumption that "once a good company always a good company". I am by no means in favor of over regulation but I have seen numerous, well known, well respected, drug companies in both the Rx and OTC channels get in trouble and be forced into consent decrees and plant closures so shouldn't we prepare for the same thing with healthcare software?

Just as there are many early, pre filing, discussions with FDA today around what clinical protocols, study requirements, human factors burdens, and mortar required for 510K or PMA submissions, couldn't we use the same approach and "pre-converse" about the specific software rather than "pre-certify" and advantage one set of developers over another.

I'd love to hear your thoughts...........