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# Notes from the MDMA Annual Meeting in D.C.
- URL: https://www.themedtechscribe.com/notes-from-the-mdma-annual-meeting-in-d-c/
- Published: 2026-10-25T16:23:43.000Z
- Updated: 2026-10-25T16:38:26.000Z
- Author: Mark McCarty
- Tags: Artificial intelligence, FDA

*(*[*Posted*](https://www.linkedin.com/in/mark-mccarty-7b93b429/recent-activity/all/?ref=themedtechscribe.com) *April 30, 2026, on LinkedIn)*

I'm here at the annual meeting of the Medical Device Manufacturers Association in Washington, D.C., and here are a few notes about remarks by FDA commissioner Marty Makary.  
  
Makary discussed a number of subjects related to pharma and biotech along with devices, but had a few words about organizational life as well. He commented that bureaucratic torpor (my words, not his) is driven largely by organization size and is a problem in both the public and private sectors. He affirmed that there are a lot of people at FDA who want to do things differently, but that it can be difficult to get people to speak up when they're in the same room as their supervisors.  
  
In that vein, Makary remarked that the IT staff at the FDA had been cut by about half – assuming I understood his remarks correctly – from about 1,500 to 700\. These staffing cuts undoubtedly drove a lot of angst among those who remained, but he said the agency's IT efforts are more focused now than in times gone by. Agency-wide, FDA intends to hire roughly 3,000 new employees over an unspecified term, although many of those will be premarket review staff.  
  
If memory serves, the agency's IT infrastructure has been the focus of a lot of concern with regard to appropriations, but there has also been a lot of talk about reducing the balkanization of IT systems between the three life science product centers. That's more an issue for combo products than single-entity products of course, but there are times when a product that seems to defy product classification/jurisdiction would benefit by a more seamless cross-center IT system if only because the expertise of more than one center would help with the review.  
  
With regard to artificial intelligence (AI), Makary said technology isn't a panacea for all things. “Sometimes we don't need AI, we just need I,” he quipped, but he seemed to suggest that Luddites might find an ally in members of the public whose fears might be amplified by a rash of bad outcomes. He reinforced the notion that the agency does not intend to conduct enforcement of a public-facing large language model (LLM) merely because a user logs in to obtain medical information, but did reiterate that any product claims regarding such a function would prompt a regulatory reaction.  
  
The next iteration of FDA's in-house AI agent, ELSA 4.0, will roll out next week, Makary said, stating that 90% of FDA staff use it and that they “love it.” Premarket reviewers need the help of this LLM to sort through all the information in premarket dossiers, but Makary seemed to suggest that some of these applications suffer from what might be described as prophylactic bloat (again, my words). Regarding the real-time clinical trials initiative, he said about 45% of clinical trial time is dead time, something that real-time clinical trial tracking should reduce significantly.  
  
More to come from this meeting, so stay tuned!