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Course Details

Course Information
  • smart_display Format

    On-Demand

  • signal_cellular_alt Difficulty Level

    Intermediate

  • work Practice Area

    Health

Date & Time
  • event Date

    Thursday, January 18, 2024

  • schedule Time

    1:00 p.m. ET./10:00 a.m. PT

  • timer Program Length

    90 minutes

Credit Information

  • This 90-minute webinar is eligible in most states for 1.5 CLE credits.

$297.00
CLE
ALL

This CLE webinar will guide healthcare practitioners through the FDA approval process for AI medical devices including Software as a Medical Device (SaMD) and the attempts by the FDA to streamline the regulatory process. The panel will discuss the FDA's recent draft guidance related to using PCCPs in marketing submissions, including drafting considerations, how PCCPs may streamline the FDA approval process, and best practices for using PCCPs.

Faculty

Kyle Y. Faget
Partner, Co-Chair Health Care Practice Group, Co-Chair Health Care & Life Sciences Sector’s Medical Device and Equipment Area of Focus
Foley & Lardner LLP

Ms. Faget advises investors, academic medical centers, physician practices, and consultants on a range of business, legal and regulatory issues affecting the telemedicine industry. She helps companies build and refine corporate compliance programs, including advising clients on regulatory and compliance matters involving the Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code and the PhRMA Code. She regularly drafts and negotiates agreements required for the development and commercialization of pharmaceutical and medical device products, including licensing agreements, collaboration agreements, clinical trial agreements, and an array services agreements.

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Mark Gardner
Directing Attorney
Gardner Law

Mr. Gardner specializes in FDA regulatory, compliance, and privacy matters. Using his real world in-house experience, combined with extensive private practice experience, which includes secondments with some of the largest healthcare companies in the world, Mr. Gardner solves multifaceted legal challenges for clients in a practical fashion. His specialties include guiding clients through complex FDA matters, performing due diligence for buyers and sellers, assessing sales and marketing programs and commercial transactions, designing and implementing compliant ways to interact with healthcare providers, facilitating government transparency reporting, and auditing and investigating company activities for compliance with the law. Mr. Gardner works with regulators at the FDA, CMS, and OCR, and with law enforcement at the DOJ and OIG. He teaches at Mitchell Hamline School of Law, University of Minnesota Law School, and University of Minnesota, Carlson School of Management.

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Description

The FDA's regulatory framework governing the approval of medical devices is time-consuming and complex, which is problematic with the advent of AI where technology is rapidly evolving. The challenge arises where certain AI software considered to be a medical device itself (SaMD) must go through the FDA's lengthy approval process, which could include re-submissions for approval under certain circumstances, that may slow the growth and development of lifesaving technology.

Such is the case with machine learning-enabled device software functions (ML-DSFs) that use algorithms to "learn" from numerous examples in a dataset without being explicitly programmed to reach a particular answer or conclusion. The FDA recognizes that the advantage of ML-DSF is the ability to improve performance through iterative modifications, which is in tension with the FDA's traditional framework for premarket review of changes to a medical device.

Therefore, in an effort to keep up with technology, the FDA is establishing a regulatory framework that will allow the agency to maintain the safety and effectiveness of medical devices without unnecessarily slowing progress. Included in this developing framework is the recently released draft guidance "Marketing Submission Recommendations for a Predetermined Change Control Plan (PCCP) for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions" which addresses the use of PCCPs that may allow manufacturers to obtain premarket authorization for pre-specified automatic and manual modifications that may be made to ML-DSFs without re-submitting the device for FDA review.

Listen as our expert panel guides practitioners through the FDA approval process for SaMD and the current status of FDA regulation for approving AI medical devices. The panel will discuss the FDA's draft guidance related to using PCCPs and best practices for compliance.

Outline

  1. Introduction: overview of traditional FDA approval process for medical devices
    1. What constitutes a medical device
    2. FDA device classification
      1. Class I
      2. Class II
      3. Class III
    3. FDA medical device approval process
      1. 510(k) clearance
      2. De novo review
      3. Premarket approval
  2. History of FDA regulatory guidance related to AI/ML medical devices
  3. AI/ML software in medical devices
    1. SaMD vs. SiMD
    2. Traditional regulatory framework and challenges for AI/ML device approval
  4. FDA draft guidance "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions"
    1. Purpose
    2. Scope
    3. Use of PCCPs
      1. Key components
      2. Drafting considerations
      3. How PCCPs may streamline the FDA approval process
  5. Case studies demonstrating approval process using PCCPs
  6. Best practices for compliance
  7. Possible future FDA AI medical device regulation

Benefits

The panel will review these and other important issues:

  • What software qualifies as a medical device requiring FDA approval?
  • How is the FDA attempting to streamline the medical device approval process to accommodate the advent of AI?
  • What is the status of the current regulatory framework for FDA approval of SaMD?
  • How can practitioners use PCCPs in market submissions?