PCCP Project

 
 

Project Session I - May 3

Download the slides.

Watch the recording of the meeting.

  • References shared:

  • Machine Learning-enabled Medical Devices: Key Terms and Definitions (link)

  • FDA Webinar on the topic from 4/13/23 (link)


April 13, 2023

FDA hosted a webinar discussing the recently released draft guidance. The webinar provided background on FDA’s patient-centered approach, scope of the guidance, modifications for ML-DSFs, and provided examples.

Access additional resources via CDRH Learn, Specialty Technical Topics

Download the slides from the webinar.


Sec. 3308 of the Consolidated Appropriations Act 2023 includes

Predetermined Change Control Plans for devices: If a predetermined change control plan is approved or cleared, then a supplemental PMA or a new 510(k) is not required for a change to a device that is consistent with such approved or cleared plan


Update March 30, 2023:

  • CDRH Issues Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Medical Devices (link)

  • Download the draft guidance (link) (download .pdf)

  • Submit comments online through 7/3/2023 (link)

  • HHS Announcement (download .pdf)

Summary:  As indicated by Sec. 3308 of the Consolidated Appropriations Act 2023 this is the subsequent guidance defining the approach to regulate predetermined change control plans.  The document includes Predetermined Change Control Plan (PCCP), Authorized Predetermined Change Control Plan (Authorized PCCP), Modification Protocol, as well as Impact Assessment.

We will host a session to review the draft guidance.


Background

One of the key elements in the proposed regulatory approach to AI/ML is the so-called Predetermined Change Control Plan (PCCP). 

A PCCP allows manufacturers to specify the types of anticipated modifications for the software and the associated methodology being used to implement those changes 

The PCCP framework will likely entail that a manufacturer defines and submits a PCCP to the FDA in a premarket submission.  Under the anticipated framework, the manufacturer can then use the PCCP to make modifications that are within the bounds of the PCCP


Aims of the Project

Highly relevant for developing a proposed regulatory framework - including through issuance of draft guidance on a predetermined change control plan (for software’s learning over time); 

We anticipate guidance to follow quickly.

We will host a session/project on Pre-determined Change Control Plan.

Aim is to

  1. capture the relevant regulatory information

  2. review PCCP

  3. establish a resource with the relevant context when the draft guidance goes live


Resources

  • Appropriations Bill (download PDF)

  • George et al., A First Look at the FDA’s Proposed Regulatory Framework for Modifications to AI-Based Software as a Medical Device (SaMD): IP Review and Strategy Guide (download PDF)

  • FDA: Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) - Discussion Paper and Request for Feedback (download PDF)

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