Medical Writers News Hubb
Advertisement Banner
  • Home
  • News
  • Papers
  • Contact
No Result
View All Result
  • Home
  • News
  • Papers
  • Contact
No Result
View All Result
Wellnessnewshubb
No Result
View All Result
Home News

FDA seeks feedback on PCCPs for AI/ML devices

admin by admin
March 31, 2023
in News


[Image courtesy of the FDA]

The FDA is responding to an ever-growing list of medical devices enabled by artificial intelligence and machine learning with new recommendations for updating AI and ML software models with pre-determined change control plans (PCCPs).

A key benefit of ML models is that they can learn to work better based on new information over time, but those changes might also introduce safety or efficacy risks in medical devices without sufficient oversight.

The FDA wants feedback on the draft guidance by July 3, 2023.

The agency published a proposal in 2019 and held public meetings and workshops with the medtech industry, patients and other stakeholders since then. In 2021 the FDA issued an action plan for AI/ML-based software as a medical device (SaMD) products.

The new draft guidance promotes the principles of the Blueprint for an AI Bill of Rights released by the Biden Administration last October. The draft guidance is applicable to machine learning-enabled device software functions (ML-DSFs) that the device manufacturer plans to modify over time, whether manually or automatically.

“This draft guidance describes an approach that would often be least burdensome and would support the ability to modify an ML-DSF while continuing to provide a reasonable assurance of safety and effectiveness across relevant patient populations,” the FDA said. “Specifically, this draft guidance proposes recommendations on the information to be included in the Predetermined Change Control Plan (PCCP) in a marketing submission for a device that is or includes an ML-DSF.”

What you need to know about PCCPs

The FDA already has the power to approve or clear PCCPs. The guidance doesn’t apply to PCCPs with only minor modifications that would not require a new submission, but rather device modifications that would otherwise require a premarket approval supplement, de novo submission or a new premarket notification.

Manufacturers that include a PCCP in a marketing submission can pre-specify intended modifications and their method of implementation to seek premarket authorization without additional submissions for every change.

“In other words, a PCCP, as part of a marketing submission, is intended to provide a means to implement modifications to an ML-DSF that generally would otherwise require additional marketing submissions prior to implementation,” the FDA said in the document.

The draft guidance covers the components of a PCCP — description of modifications, modification protocol, and impact assessment — as well as how to establish a PCCP through different regulatory pathways and how to identify a PCCP in a marketing submission.

The document also explains how to implement device modifications after a PCCP has been authorized, and how to modify a PCCP for an authorized device.

In Appendix B, the FDA offers examples of PCCP scenarios for ML models in software for patient monitoring, skin lesion analysis, ventilator settings, image acquisition assistance and feeding tube placement radiograph analysis.

Related: AI breakthroughs in medtech: 7 ways to enhance healthcare



Source link

Previous Post

Study predicts the country-specific impact of maternal vaccination against respiratory syncytial virus

Next Post

What impact does BMI have on the psychological health of oldest old individuals?

Next Post

What impact does BMI have on the psychological health of oldest old individuals?

Recommended

What Does It Take to Be a Medical Editor? Exploring Editing Careers

5 months ago

Parkinson’s progression tracked by at-home device from MIT

9 months ago

Promising targeted therapy offers new hope to certain patients with advanced pancreatic cancer

2 days ago

How medtech giant Cardinal Health is prioritizing sustainability

2 months ago

Insulin deficiency leads to reduced pancreas size in type 1 diabetes

3 months ago

Avoid These Common Supplement Formulation Mistakes

5 months ago
Medical-Writers-(-white-)

© Medical Writers News Hubb All rights reserved.

Use of these names, logos, and brands does not imply endorsement unless specified. By using this site, you agree to the Privacy Policy and Terms & Conditions.

Navigate Site

  • Home
  • News
  • Papers
  • Contact

Newsletter Sign Up.

No Result
View All Result
  • Home
  • News
  • Papers
  • Contact

© 2022 Medical Writers News Hubb All rights reserved.