After the 2024 FDA guidance, adoption of Predetermined Change Control Plans (PCCPs) increased among radiology AI devices, but better reporting transparency is needed. https://doi.org/10.1148/ryai.260385 #FDA #RegulatoryScience #AI
September 22, 2026 at 11:15 AM
After the 2024 FDA guidance, adoption of Predetermined Change Control Plans (PCCPs) increased among radiology AI devices, but better reporting transparency is needed. https://doi.org/10.1148/ryai.260385 #FDA #RegulatoryScience #AI
After the 2024 FDA guidance, adoption of Predetermined Change Control Plans (PCCPs) increased among radiology AI devices, but better reporting transparency is needed. https://doi.org/10.1148/ryai.260385 #RadiologyAI #AI #MachineLearning
September 13, 2026 at 7:15 AM
After the 2024 FDA guidance, adoption of Predetermined Change Control Plans (PCCPs) increased among radiology AI devices, but better reporting transparency is needed. https://doi.org/10.1148/ryai.260385 #RadiologyAI #AI #MachineLearning
After the 2024 FDA guidance, adoption of Predetermined Change Control Plans (PCCPs) increased among radiology AI devices, but better reporting transparency is needed. https://doi.org/10.1148/ryai.260385 #FDA #RadiologyAI #ML
September 16, 2026 at 11:15 AM
After the 2024 FDA guidance, adoption of Predetermined Change Control Plans (PCCPs) increased among radiology AI devices, but better reporting transparency is needed. https://doi.org/10.1148/ryai.260385 #FDA #RadiologyAI #ML
After the 2024 FDA guidance, adoption of Predetermined Change Control Plans (PCCPs) increased among radiology AI devices, but better reporting transparency is needed. https://doi.org/10.1148/ryai.260385 #AOCMP2026 #medphys #RadPhys #radiology
September 10, 2026 at 7:15 AM
After the 2024 FDA guidance, adoption of Predetermined Change Control Plans (PCCPs) increased among radiology AI devices, but better reporting transparency is needed. https://doi.org/10.1148/ryai.260385 #AOCMP2026 #medphys #RadPhys #radiology
After the 2024 FDA guidance, adoption of Predetermined Change Control Plans (PCCPs) increased among radiology AI devices, but better reporting transparency is needed. https://doi.org/10.1148/ryai.260385 #RadiologyAI #AI #ML
September 18, 2026 at 11:15 AM
After the 2024 FDA guidance, adoption of Predetermined Change Control Plans (PCCPs) increased among radiology AI devices, but better reporting transparency is needed. https://doi.org/10.1148/ryai.260385 #RadiologyAI #AI #ML
Like I’ve agreed with you when you talked about the damage pccps done, but this is completely hypocritical and off base
March 30, 2025 at 1:46 AM
Like I’ve agreed with you when you talked about the damage pccps done, but this is completely hypocritical and off base
Accelerating Innovation in Medical Devices through PCCPs and CI/CD Strategies#Canada#Toronto#Medical_Devices#CI/CD#PCCPs
Accelerating Innovation in Medical Devices through PCCPs and CI/CD Strategies
Explore how Predetermined Change Control Plans (PCCPs) can enhance the speed and compliance of software updates in medical devices. Join our informative webinar!
third-news.com
March 16, 2026 at 12:47 PM
Accelerating Innovation in Medical Devices through PCCPs and CI/CD Strategies#Canada#Toronto#Medical_Devices#CI/CD#PCCPs
After the 2024 FDA guidance, adoption of Predetermined Change Control Plans (PCCPs) increased among radiology AI devices, but better reporting transparency is needed. https://doi.org/10.1148/ryai.260385 #FDA #AI #ML
September 15, 2026 at 7:15 AM
After the 2024 FDA guidance, adoption of Predetermined Change Control Plans (PCCPs) increased among radiology AI devices, but better reporting transparency is needed. https://doi.org/10.1148/ryai.260385 #FDA #AI #ML
After the 2024 FDA guidance, adoption of Predetermined Change Control Plans (PCCPs) increased among radiology AI devices, but better reporting transparency is needed. https://doi.org/10.1148/ryai.260385 #AOCMP2026 #medphys #RadPhys #radiology
September 11, 2026 at 7:15 AM
After the 2024 FDA guidance, adoption of Predetermined Change Control Plans (PCCPs) increased among radiology AI devices, but better reporting transparency is needed. https://doi.org/10.1148/ryai.260385 #AOCMP2026 #medphys #RadPhys #radiology
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!
May 21, 2025 at 5:19 AM
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!
Back of the envelope estimates: FDA has authorized about 250 medical devices with predetermined change control plans (PCCPs). In July alone, 21 devices from 18 manufacturers received authorizations that included PCCPs.
August 22, 2026 at 2:25 AM
Back of the envelope estimates: FDA has authorized about 250 medical devices with predetermined change control plans (PCCPs). In July alone, 21 devices from 18 manufacturers received authorizations that included PCCPs.
especially when there hasn’t ever been a real apology not littered with excuses. how are you going to repost pccps apology and talk about how bad it is yet come to me and say buukkins was well thought out and actually an apology?? and not just an “oh shit i fucked up” moment
March 26, 2025 at 6:03 PM
especially when there hasn’t ever been a real apology not littered with excuses. how are you going to repost pccps apology and talk about how bad it is yet come to me and say buukkins was well thought out and actually an apology?? and not just an “oh shit i fucked up” moment
#PCCP for #AI -enabled #MedDevice What do you think of the latest version?
www.linkedin.com/posts/sonjaf...
www.linkedin.com/posts/sonjaf...
Sonja Fulmer on LinkedIn: Predetermined Change Control Plan for Artificial Intelligence-Enabled
I’m happy to share that today we have published the final guidance on predetermined change control plans (PCCPs) for AI-enabled device software functions. For…
www.linkedin.com
December 3, 2024 at 6:10 PM
#PCCP for #AI -enabled #MedDevice What do you think of the latest version?
www.linkedin.com/posts/sonjaf...
www.linkedin.com/posts/sonjaf...
I'm looking forward to a day when PCCPs are common enough that these numbers stop being interesting. In the meantime, it's encouraging to see the pace picking up.
August 22, 2026 at 2:25 AM
I'm looking forward to a day when PCCPs are common enough that these numbers stop being interesting. In the meantime, it's encouraging to see the pace picking up.
After the law was enacted in December of 2022, it took almost a year and a half for that many unique manufacturers to obtain authorizations for devices with PCCPs under the new framework.
August 22, 2026 at 2:25 AM
After the law was enacted in December of 2022, it took almost a year and a half for that many unique manufacturers to obtain authorizations for devices with PCCPs under the new framework.
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...
www.boleary.com/blog/posts/2...
June 10, 2025 at 7:47 PM
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...
www.boleary.com/blog/posts/2...
It looks like we may now have 50+ medical devices with FDA-authorized predetermined change control plans (PCCPs).
www.boleary.com/blog/posts/2...
www.boleary.com/blog/posts/2...
List of FDA authorized devices with Predetermined Change Control Plans – Brendan O’Leary
This page lists medical devices that have FDA authorized Predetermined Change Control Plans (PCCPs) based on searches of device authorization letters and approval order statements.
www.boleary.com
December 19, 2024 at 12:15 AM
It looks like we may now have 50+ medical devices with FDA-authorized predetermined change control plans (PCCPs).
www.boleary.com/blog/posts/2...
www.boleary.com/blog/posts/2...
The FDA finalized its guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled devices.
Predetermined Change Control Plan for Artificial Intelligence-Enabled
Marketing Submission Recommendations for Predetermined Change Control Plans for AI/ML-Enabled Device Software Functions
www.fda.gov
December 3, 2024 at 2:52 PM
The FDA finalized its guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled devices.
A Predetermined Change Control Plan (PCCP) can enable significant planned modifications to be made to a medical device after the device and the plans to modify the device have been reviewed by the FDA. More about PCCPs and devices with FDA authorized PCCPs: www.boleary.com/blog/posts/2...
Finding FDA authorized devices with Predetermined Change Control Plans – Brendan O’Leary
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 (PCCPs). A PCCP can enable signifi...
www.boleary.com
August 20, 2024 at 2:11 PM
A Predetermined Change Control Plan (PCCP) can enable significant planned modifications to be made to a medical device after the device and the plans to modify the device have been reviewed by the FDA. More about PCCPs and devices with FDA authorized PCCPs: www.boleary.com/blog/posts/2...
FDA Device Guidance Agenda: What to Watch in 2026 AI, real-world evidence, PCCPs, and patient preference information top the list
FDA Device Guidance Agenda: What to Watch in 2026 AI, real-world evidence, PCCPs, and patient preference information top the list
The U.S. Food and Drug Administration (FDA) has published its guidance agenda for Fiscal Year 2026, announcing plans for eight guidance documents...
www.jdsupra.com
October 17, 2025 at 11:48 PM
FDA Device Guidance Agenda: What to Watch in 2026 AI, real-world evidence, PCCPs, and patient preference information top the list
Keeping up With AI: FDA Issues Guidance on Predetermined Change Control Plans (PCCPs) for Artificial Intelligence (AI)-Enabled Devices
Keeping up With AI: FDA Issues Guidance on Predetermined Change Control Plans (PCCPs) for Artificial Intelligence (AI)-Enabled Devices
On August 18, 2025, the Food and Drug Administration (FDA) issued guidance (Marketing Submission Recommendations for a Predetermined Change...
www.jdsupra.com
September 18, 2025 at 10:02 PM
Keeping up With AI: FDA Issues Guidance on Predetermined Change Control Plans (PCCPs) for Artificial Intelligence (AI)-Enabled Devices
Streamlining Device Changes with Predetermined Change Control Plans (PCCPs)
Streamlining Device Changes with Predetermined Change Control Plans (PCCPs)
In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that...
www.jdsupra.com
January 15, 2025 at 2:50 PM
Streamlining Device Changes with Predetermined Change Control Plans (PCCPs)
FDA Device Guidance Agenda: What to Watch in 2026 AI, real-world evidence, PCCPs, and patient preference information top the list
FDA Device Guidance Agenda: What to Watch in 2026 AI, real-world evidence, PCCPs, and patient preference information top the list
The U.S. Food and Drug Administration (FDA) has published its guidance agenda for Fiscal Year 2026, announcing plans for eight guidance documents...
www.jdsupra.com
October 17, 2025 at 11:48 PM
FDA Device Guidance Agenda: What to Watch in 2026 AI, real-world evidence, PCCPs, and patient preference information top the list
Keeping up With AI: FDA Issues Guidance on Predetermined Change Control Plans (PCCPs) for Artificial Intelligence (AI)-Enabled Devices
Keeping up With AI: FDA Issues Guidance on Predetermined Change Control Plans (PCCPs) for Artificial Intelligence (AI)-Enabled Devices
On August 18, 2025, the Food and Drug Administration (FDA) issued guidance (Marketing Submission Recommendations for a Predetermined Change...
www.jdsupra.com
September 18, 2025 at 10:02 PM
Keeping up With AI: FDA Issues Guidance on Predetermined Change Control Plans (PCCPs) for Artificial Intelligence (AI)-Enabled Devices