Brendan O’Leary

List of FDA authorized devices with Predetermined Change Control Plans

This page lists medical devices that have FDA authorized Predetermined Change Control Plans (PCCPs) based on searches of device authorization letters and approval order…

Brendan O’Leary

Finding FDA authorized devices with Predetermined Change Control Plans

In December 2022, the Food and Drug Omnibus Reform Act of 2022 provided the FDA with new authority related to the authorization of Predetermined Change Control Plans…

Brendan O’Leary

A transatlantic take on medical device regulation

I enjoyed having this conversation with Dr. Annabelle Painter and Johan Ordish about AI and medical device regulation. The RSM Digital Health Section Podcast is always worth…

Brendan O’Leary

Listener Effort is a promising digital measure in ALS research

This preprint [1] covers several important advances in the development of new digital-enabled measures of ALS progression:

Brendan O’Leary

“We don’t have a national active monitoring system for pandemic potential diseases, and it’s kind of crazy…”

Steven Roach of the Food Animal Concerns Trust, as quoted in STAT’s article on the USDA and FDA turf battles that are hampering responses to outbreaks like H5N1 bird flu:

Brendan O’Leary

EHRs bury critical information about hearing status

We rely on Electronic Health Records (EHRs) to inform the care team about an individual’s hearing loss or deafness. EHR systems bury this critical information, and care…

Brendan O’Leary

Downloadable spreadsheets and graphs of the FDA’s medical device review performance metrics

The FDA publishes quarterly and annual reports that include performance metrics for the medical device review process. These reports can include thousands of performance…

Brendan O’Leary

Regulatory considerations for digital surrogate endpoint response biomarkers

On July 24, 2023, I gave a “quick” talk on regulatory considerations at the EverythingALS Digital Biomarkers Summit. This post is adapted from that talk.

Brendan O’Leary

Taxpayers should demand better

Shutdowns are among the biggest causes of government waste that I observed in my fourteen years as a federal employee. Shutdowns inflict irreparable harm on the federal…

Brendan O’Leary

“We are making critical clinical trial decisions on measures that we know are bad”

Christine Cong Guo of ActiGraph hit the nail on the head in a discussion with STAT’s Mario Aguilar:

Brendan O’Leary

Data for researchers: Extracted text from more than 72,000 FDA medical device 510(k) summaries

Every year, the FDA clears around 3,000 medical devices to enter the U.S. market through a review pathway known as the 510(k) program. Descriptions of the data and…

Brendan O’Leary

Plots for MDUFA wonks

Plots for MDUFA wonks, with the caveat that efficiency/speed metrics only tell part of the story, especially when quality metrics are not readily available: https://www.fdada…

Brendan O’Leary

A promise that should not have been made

A good read from Allison DeAngelis at STAT: The inside story of how data integrity issues roiled a biotech seen as ‘Moderna 2.0’

Brendan O’Leary

AIM-HI: Supporting prospective evaluations of diagnostic AI/ML tools in real-world clinical settings

AIM-HI: “…an effort to stimulate the generation of higher quality evidence of clinical AI safety, effectiveness and fairness.” Sign me up! I’m honored to join the National…

Brendan O’Leary

Four things to know about the FDA’s new discussion paper on AI/ML in drug development

First, a big congratulations to the great folks at the FDA who got this out the door! Here are four key points from the FDA’s discussion paper on Using AI & ML in the…

Brendan O’Leary