It’s easy to blame social media for contributing to our shorter attention spans, and to lament the loss of long form blog writing. To which I say…wait, I lost my train of thought. Oh yeah! To which I say, behold! No, that wasn’t it - oh never mind. Welcome to my next gen blog.

VALID Act, Part III. Like a scene from a zombie movie, this thing just won’t stay dead. Reintroduced in March of this year, the bill’s sponsors are once again trying to make the case for more FDA oversight of LDTs. Key takeaways:

Recap. The bill would allow the FDA to regulate LDTs directly, using a risk-based approach. Vast majority of tests would be lightly regulated through a certification process. High risk devices would need to go through agency review.
Fresh Tactics. AdvaMed released on March 29 their response to the Senate HELP committee request for comment on Pandemic All-Hazards Preparedness Act, which the Senate is reviewing for re-authorization. Included with all of the other comments about the need for stockpiling and more innovative IVD development tools was an ‘oh by the way’ section on page 7 about how it would be really great if Congress passed the VALID act.
Old School Tactics. FDA has noted publicly that - while their strong preference is legislation - they are looking at rule-making as an option to more closely regulate LDTs.

Clinical Decision Software Guidance. In September 2022, FDA issued final guidance on Clinical Decision Software (CDS). In a classic example of regulatory language, the agency laid out what isn’t considered CDS. Apparently this was easier than describing what was CDS. Highlights:

What it’s not. As long as the software does directly “acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device”, it is not CDS. In other words, if the data provided by the software is the same information you get by talking directly to your HCP, it’s not CDS.
What it’s also not.Provided the software only provides recommendations, and isn’t a key input to treatment decisions, it is not CDS. Implied in this is the idea that there’s no ‘black box’ analysis done by the software, only a full presentation of the data to the HCP.
If it’s not, it therefore must be. Yes, it is safe to assume that anything other than software functions listed above would be considered CDS.

Draft Guidance on Changes to AI-based Software Devices. In what has to be a record for the longest title of a guidance document in FDA history, the agency discusses a proposal to allow for changes to device software after clearance or approval which is actually pretty innovative. Key points:

Wow. The FDA will consider allowing manufacturers to make changes to software post-market without a new application, provided those changes are described in a Predetermined Change Control Plan (PCCP). This would allow software containing AI/ML components to be modified without filing a new submission.
Really? A PCCP must be submitted in a marketing application (510k, PMA) and approved by the FDA before changes can be made post-market. Once approved, manufacturers can make changes without FDA review provided they follow the plan.
As caveats go, this isn’t too bad. Any modifications to an approved PCCP must be submitted and approved to the agency prior to implementation. The FDA would consider changes to a PCCP the same way it considers changes to any device with marketing authorization.