Brendan O'Leary
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Brendan O'Leary
@boleary.com
180 followers 810 following 110 posts
Engineer, MedTech consultant, and former regulator.

(he/him)
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@alecgaffney.bsky.social in yesterday's "FDA Today" newsletter: "Needless to say, most emails from center directors to their staff do not contain instructions on how those team members can resign."
GET ON BOARD OR GET OUT: One sign that Prasad is anticipating pushback from CBER staff about this policy shift is his encouragement of some employees to resign. Toward the end of his email, Prasad wrote that he believes debates about CBER’s vaccine policies “should be private, internal to FDA, until they are ready to be made public. I don't endorse selective reporting of our meetings and documents. Some staff may not agree with these core principles and operating principles. Please submit your resignation letters to your supervisor and CC my deputy Katherine Szarama,” he wrote. “For those who choose to remain in CBER, I look forward to working with you, learning from you, discussing with you, and interacting with you on our shared mission: to elevate vaccine science to 21st century evidence based medicine.” Prasad’s email also frequently laments leaks to the media, which he called “unethical, illegal and … factually incorrect.” Needless to say, most emails from center directors to their staff do not contain instructions on how those team members can resign.
December 3, 2025 at 1:27 PM
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This is a despicable politicization of FDA.gov, and we should all demand better.
A screenshot of FDA.gov, including political statements about the government shutdown.
October 1, 2025 at 11:08 PM
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Potential coordinated investigational use ("regulatory sandboxes") of AI/ML-enabled medical devices is featured in the action plan the White House published today.

www.whitehouse.gov/wp-content/u...
Enable AI Adoption Today, the bottleneck to harnessing AI’s full potential is not necessarily the availability of models, tools, or applications. Rather, it is the limited and slow adoption of AI, particularly within large, established organizations. Many of America’s most critical sectors, such as healthcare, are especially slow to adopt due to a variety of factors, including distrust or lack of understanding of the technology, a complex regulatory landscape, and a lack of clear governance and risk mitigation standards. A coordinated Federal effort would be beneficial in establishing a dynamic, “try-first” culture for AI across American industry. Recommended Policy Actions • Establish regulatory sandboxes or AI Centers of Excellence around the country where researchers, startups, and established enterprises can rapidly deploy and test AI tools while committing to open sharing of data and results. These efforts would be enabled by regulatory agencies such as the Food and Drug Administration (FDA) and the Securities and Exchange Commission (SEC), with support from DOC through its AI evaluation initiatives at NIST.
July 23, 2025 at 9:47 PM
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Are there really 100+ medical devices with FDA-authorized predetermined change control plans (PCCPs)? Probably not: I think this dataset has some likely false positives in it. But we're getting closer...

www.boleary.com/blog/posts/2...
A line chart showing the approximate cumulative total number of FDA authorized medical devices with predetermined change control plans (PCCPs). There has been an increase recently.
June 10, 2025 at 7:47 PM
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52 republican senators, including many who knew better but made a cowardly choice, provided the confirmation votes that led to this. Among republicans, McConnell alone voted against Sec. Kennedy's confirmation. Will any others find their backbones now?

www.senate.gov/legislative/...
YEAs ---52 Banks (R-IN) Barrasso (R-WY) Blackburn (R-TN) Boozman (R-AR) Britt (R-AL) Budd (R-NC) Capito (R-WV) Cassidy (R-LA) Collins (R-ME) Cornyn (R-TX) Cotton (R-AR) Cramer (R-ND) Crapo (R-ID) Cruz (R-TX) Curtis (R-UT) Daines (R-MT) Ernst (R-IA) Fischer (R-NE) Graham (R-SC) Grassley (R-IA) Hagerty (R-TN) Hawley (R-MO) Hoeven (R-ND) Husted (R-OH) Hyde-Smith (R-MS) Johnson (R-WI) Justice (R-WV) Kennedy (R-LA) Lankford (R-OK) Lee (R-UT) Lummis (R-WY) Marshall (R-KS) McCormick (R-PA) Moody (R-FL) Moran (R-KS) Moreno (R-OH) Mullin (R-OK) Murkowski (R-AK) Paul (R-KY) Ricketts (R-NE) Risch (R-ID) Rounds (R-SD) Schmitt (R-MO) Scott (R-FL) Scott (R-SC) Sheehy (R-MT) Sullivan (R-AK) Thune (R-SD) Tillis (R-NC) Tuberville (R-AL) Wicker (R-MS) Young (R-IN)
June 9, 2025 at 9:23 PM
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Civil servants at the FDA have made it easier to find medical devices with FDA authorized predetermined change control plans (PCCPs) in the agency's premarket databases. Nice work!
A screenshot of the FDA's 510(k) database showing a new checkbox for PCCPs.
May 21, 2025 at 5:19 AM
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‘We Can Bury Anyone’: Inside a Hollywood Smear Machine — Gift link: www.nytimes.com/2024/12/21/b...
"Of course- but you know when we send over documents we can't send over the work we will or could do because that could get us in a lot of trouble," Ms. Nathan responded, adding, "We can't write we will destroy her." Moments later, she said, "Imagine if a document saying all the things that he wants ends up in the wrong hands." "You know we can bury anyone," she wrote.
December 21, 2024 at 5:52 PM