• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    Optimize EP Launches CaRM Cardiac Device Data Management Platform

    U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

    FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR

    Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

    Moon Surgical Expands Leadership Team
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Fixing Face Mask Form and Function

    The Heart of the Matter: Trends in Cardiology

    Virtually the Same? The Challenges of Online Conferences

    Digital Health Delivers During a Year for the Ages

    Advanced Technology for Staking and Swaging Medical Plastics
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    maxon

    MW Life Sciences

    PTI Engineered Plastics Inc.

    Spectrum Plastics Group

    FUTEK Advanced Sensor Technology Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Meeting Critical Ventilator Product Requirements Amid Pandemic

    Impact of COVID-19 on the Medtech Supply Chain

    Finding the Upside to a Challenging Year

    Preparing Your Design Controls for FDA Approval

    A 'Trial and Error' Approach to Micromolded Parts
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Creganna Medical, part of TE Connectivity

    FUTEK Advanced Sensor Technology Inc.

    MW Life Sciences

    K-Tube Technologies

    Element
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • Podcasts
    • Resources
    • eBook
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    A New, Tailored Review Framework for Artificial Intelligence-Based Devices

    The FDA is exploring a framework that would allow for modifications to algorithms to be made from real-world learning and adaptation.

    A New, Tailored Review Framework for Artificial Intelligence-Based Devices
    The goal of the framework is to assure that ongoing algorithm changes follow pre-specified performance objectives and change control plans, use a validation process that ensures improvements to the performance, safety, and effectiveness of the artificial intelligence software, and includes real-world monitoring of performance once the device is on the market to ensure safety and effectiveness are maintained.
    Related CONTENT
    • An Update on the 2020 Presidential Election and Recent Regulatory Changes
    • The FDA Wants to Bring Manufacturing ‘Home’
    • RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device
    • FDA OKs SentiAR's Holographic Cardiac Ablation Guidance System
    • FDA OKs Masimo’s Rad-G Pulse Oximeter
    Scott Gottlieb, M.D. , Commissioner, U.S. Food and Drug Administration04.03.19
    Artificial intelligence and machine learning have the potential to fundamentally transform the delivery of health care. As technology and science advance, we can expect to see earlier disease detection, more accurate diagnosis, more targeted therapies and significant improvements in personalized medicine.
     
    The ability of artificial intelligence and machine learning software to learn from real-world feedback and improve its performance is spurring innovation and leading to the development of novel medical devices.
     
    Today, we’re announcing steps to consider a new regulatory framework specifically tailored to promote the development of safe and effective medical devices that use advanced artificial intelligence algorithms.
     
    Artificial intelligence algorithms are software that can learn from and act on data. These types of algorithms are already being used to aid in screening for diseases and to provide treatment recommendations. Last year, the FDA authorized an artificial intelligence based device for detecting diabetic retinopathy, an eye disease that can cause vision loss. The agency also authorized a second artificial intelligence based device for alerting providers of a potential stroke in patients.
     
    The authorization of these technologies was a harbinger of progress that the FDA expects to see as more medical devices incorporate advanced artificial intelligence algorithms to improve their performance and safety. Artificial intelligence has helped transform industries like finance and manufacturing, and I’m confident that these technologies will have a profound and positive impact on health care. I can envision a world where, one day, artificial intelligence can help detect and treat challenging health problems, for example by recognizing the signs of disease well in advance of what we can do today. These tools can provide more time for intervention, identifying effective therapies and ultimately saving lives.
     
    We’re taking the first step toward developing a novel and tailored approach to help developers bring artificial intelligence devices to market by releasing a discussion paper. Other steps in the future will include issuing draft guidance that will be informed by the input we receive. Our approach will focus on the continually-evolving nature of these promising technologies. We plan to apply our current authorities in new ways to keep up with the rapid pace of innovation and ensure the safety of these devices.
     
    The artificial intelligence technologies granted marketing authorization and cleared by the agency so far are generally called “locked” algorithms that don’t continually adapt or learn every time the algorithm is used. These locked algorithms are modified by the manufacturer at intervals, which includes “training” of the algorithm using new data, followed by manual verification and validation of the updated algorithm. But there’s a great deal of promise beyond locked algorithms that’s ripe for application in the health care space, and which requires careful oversight to ensure the benefits of these advanced technologies outweigh the risks to patients. These machine learning algorithms that continually evolve, often called “adaptive” or “continuously learning” algorithms, don’t need manual modification to incorporate learning or updates. Adaptive algorithms can learn from new user data presented to the algorithm through real-world use. For example, an algorithm that detects breast cancer lesions on mammograms could learn to improve the confidence with which it identifies lesions as cancerous or may learn to identify specific subtypes of breast cancer by continually learning from real-world use and feedback.
     
    We are exploring a framework that would allow for modifications to algorithms to be made from real-world learning and adaptation, while still ensuring safety and effectiveness of the software as a medical device is maintained. A new approach to these technologies would address the need for the algorithms to learn and adapt when used in the real world. It would be a more tailored fit than our existing regulatory paradigm for software as a medical device. For traditional software as a medical device, when modifications are made that could significantly affect the safety or effectiveness of the device, a sponsor must make a submission demonstrating the safety and effectiveness of the modifications. With artificial intelligence, because the device evolves based on what it learns while it’s in real-world use, we’re working to develop an appropriate framework that allows the software to evolve in ways to improve its performance while ensuring that changes meet our gold standard for safety and effectiveness throughout the product’s lifecycle—from premarket design throughout the device’s use on the market. Our ideas are the foundational first step to developing a total product lifecycle approach to regulating these algorithms that use real-world data to adapt and improve.
     
    We’re considering how an approach that enables the evaluation and monitoring of a software product from its premarket development to post-market performance could provide reasonable assurance of safety and effectiveness and allow the FDA’s regulatory oversight to embrace the iterative nature of these artificial intelligence products while ensuring that our standards for safety and effectiveness are maintained. This first step in developing our approach outlines information specific to devices that include artificial intelligence algorithms that make real-world modifications that the agency might require for premarket review. They include the algorithm’s performance, the manufacturer’s plan for modifications and the ability of the manufacturer to manage and control risks of the modifications.
     
    The agency may also intend to review what’s referred to as software’s predetermined change control plan. The predetermined change control plan would provide detailed information to the agency about the types of anticipated modifications based on the algorithm’s re-training and update strategy, and the associated methodology being used to implement those changes in a controlled manner that manages risks to patients. Consistent with our existing quality systems regulation, the agency expects software developers to have an established quality system that is geared towards developing, delivering and maintaining high-quality products throughout the lifecycle that conforms to the agency’s standards and regulations.
     
    The goal of the framework is to assure that ongoing algorithm changes follow pre-specified performance objectives and change control plans, use a validation process that ensures improvements to the performance, safety, and effectiveness of the artificial intelligence software, and includes real-world monitoring of performance once the device is on the market to ensure safety and effectiveness are maintained. We’re exploring this approach because we believe that it will enable beneficial and innovative artificial intelligence software to come to market while still ensuring the device’s benefits continue to outweigh its risks.
     
    We have more work to do to build out this initial set of ideas and we’ll rely on comments and feedback from experts and stakeholders in this space to help inform the agency as we continue to think about how we’ll regulate artificial intelligence technologies to improve patient care. We anticipate several more steps in the future, including issuing draft guidance that’ll be informed by the feedback on today’s discussion paper.
     
    As with all of our efforts in digital health, collaboration will be key to developing this appropriate framework. We encourage feedback and welcome a diversity of opinions and thoughtful discourse, which will contribute to building the foundation of this regulatory paradigm. As algorithms evolve, the FDA must also modernize our approach to regulating these products. We must ensure that we can continue to provide a gold standard of safety and effectiveness. We believe that guidance from the agency will help advance the development of these innovative products.
     
    We’ve taken similar steps to advance other novel oversight frameworks for new technologies. Our Digital Health Innovation Action Plan laid the groundwork for new approaches to foster innovation in digital health. We’re building our Digital Health Center of Excellence to develop more efficient ways to ensure the safety and effectiveness of technologies like smart watches with medical apps. Our Software Precertification Pilot Program is allowing us to test a new approach for product review. While I know there are more steps to take in our regulation of artificial intelligence algorithms, the first step taken today will help promote ideas on the development of safe, beneficial and innovative medical products.
    Related Searches
    • manufacturer
    • apps
    • premarket review
    • it
    Related Knowledge Center
    • Digital Health
    • Software & IT
    Suggested For You
    An Update on the 2020 Presidential Election and Recent Regulatory Changes An Update on the 2020 Presidential Election and Recent Regulatory Changes
    The FDA Wants to Bring Manufacturing ‘Home’ The FDA Wants to Bring Manufacturing ‘Home’
    RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device
    FDA OKs SentiAR FDA OKs SentiAR's Holographic Cardiac Ablation Guidance System
    FDA OKs Masimo’s Rad-G Pulse Oximeter FDA OKs Masimo’s Rad-G Pulse Oximeter
    FDA Clears Scientia Vascular FDA Clears Scientia Vascular's Zoom Wire
    Let’s Build This: Best Practices for Utilizing External Regulatory Expertise Let’s Build This: Best Practices for Utilizing External Regulatory Expertise
    FDA Authorizes First Point-of-Care COVID-19 Antibody Test FDA Authorizes First Point-of-Care COVID-19 Antibody Test
    FDA OKs Surmodics FDA OKs Surmodics' Pounce Thrombus Retrieval System
    FDA Launches the Digital Health Center of Excellence FDA Launches the Digital Health Center of Excellence
    Acutus AcQMap Catheter Cleared by FDA Acutus AcQMap Catheter Cleared by FDA
    FDA OKs Varian FDA OKs Varian's Eclipse v16.1 Proton Therapy Treatment Planning Software
    FDA Approves Expanded Use of Roche FDA Approves Expanded Use of Roche's CINtec PLUS Cytology Test
    FDA Publishes COVID-19 Molecular Dx Test Comparative Performance Data FDA Publishes COVID-19 Molecular Dx Test Comparative Performance Data
    HD Medical Awarded FDA Clearance for HD Steth HD Medical Awarded FDA Clearance for HD Steth

    Related Breaking News

    • Digital Health | Software & IT
      FDA Releases Artificial Intelligence, Machine Learning Action Plan

      FDA Releases Artificial Intelligence, Machine Learning Action Plan

      Outlines FDA’s next steps toward furthering oversight for AI/ML-based "software as a medical device."
      U.S. Food and Drug Administration 01.13.21

    • Chronic Disease | Digital Health | Patient Monitoring
      Teladoc Health, Dexcom Launch CGM Tech, Personalized Insights for Type 2 Diabetes

      Teladoc Health, Dexcom Launch CGM Tech, Personalized Insights for Type 2 Diabetes

      CGM-powered insights offer complete health profile, recommendations that support ongoing diabetes management.
      GlobeNewswire 01.13.21

    • Software & IT
      Censis Technologies, Cantel Medical Partner on Endoscope Reprocessing Software Solution

      Censis Technologies, Cantel Medical Partner on Endoscope Reprocessing Software Solution

      Companies developing an enhanced integrated workflow solution designed to provide superior infection prevention and practice optimization.
      Business Wire 01.07.21


    • Digital Health
      Digital Medicine Key to Revolutionizing Patient Health Outcomes

      Digital Medicine Key to Revolutionizing Patient Health Outcomes

      The global COVID-19 pandemic emphasized the need for digital medicine in improving health.
      GlobalData 12.14.20

    • Digital Health
      New Software Supports Increased Demand for Personalized Medical Devices

      New Software Supports Increased Demand for Personalized Medical Devices

      SurgiCase streamlines collaboration between medical device companies and clinicians.
      Materialise N.V. 12.10.20

    • Patient Monitoring | Software & IT
      AI Metrics

      AI Metrics' Liver Imaging Software Earns FDA Nod

      Early-stage startup approved for low-cost, low-risk, non-invasive procedures for chronic liver disease patients.
      University of Alabama at Birmingham 12.09.20


    • Digital Health
      FDA OKs AireHealth

      FDA OKs AireHealth's VitalMed Connected Nebulizer

      Bluetooth-enabled, portable nebulizer will help track symptoms and support medication adherence.
      Business Wire 12.09.20

    • Diagnostics | Software & IT
      FDA OKs Hologic

      FDA OKs Hologic's Genius AI Breast Cancer Detection Software

      New deep-learning algorithm helps radiologists detect breast cancers in their early stages.
      Business Wire 12.01.20

    • Diagnostics | Software & IT
      RSNA News: Royal Philips Introduces IntelliSpace Portal 12

      RSNA News: Royal Philips Introduces IntelliSpace Portal 12

      A next-gen Advanced Visualization Workspace with AI capabilities.
      Royal Philips 11.30.20


    • Software & IT
      GE Healthcare Launches X-ray AI for COVID-19 Patients

      GE Healthcare Launches X-ray AI for COVID-19 Patients' Endotracheal Tube Placement

      A necessary and important step when ventilating critically ill COVID-19 patients.
      Business Wire 11.23.20

    • Digital Health
      Avail Medsystems Raises $100 Million in Series B Funding

      Avail Medsystems Raises $100 Million in Series B Funding

      Money will help the company meet demand for procedural telemedicine technology in the operating room.
      Business Wire 11.17.20

    • Software & IT
      BD Acquires CUBEX

      BD Acquires CUBEX's Medical Business

      Broadens automated dispensing portfolio across care continuum.
      PR Newswire 11.12.20


    • Digital Health
      Telehealth Patient Satisfaction Surges During Pandemic But Barriers to Access Remain

      Telehealth Patient Satisfaction Surges During Pandemic But Barriers to Access Remain

      Study finds that 46 percent of patients chose telehealth services for safety reasons.
      Business Wire 11.11.20

    • Cardiovascular | Digital Health
      FDA OKs Aidoc

      FDA OKs Aidoc's AI Triage of Incidental Pulmonary Embolism

      Further solidifies leadership as the most comprehensive acute AI vendor in the market.
      PR Newswire 10.21.20

    • Digital Health | Software & IT
      GE Healthcare Introduces Edison HealthLink

      GE Healthcare Introduces Edison HealthLink

      New edge technology is designed to give clinicians rapid access to critical data.
      PR Newswire 10.14.20


    Trending
    • Cytotron Gains Breakthrough Status To Treat Breast, Liver, And Pancreatic Cancers
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Hardy Diagnostics Releases Rapid Test For COVID-19
    • Top 10 Trends In The Medical Device And Equipment Industry
    Breaking News
    • Optimize EP Launches CaRM Cardiac Device Data Management Platform
    • U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030
    • FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR
    • Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation
    • Moon Surgical Expands Leadership Team
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Pharmaceutical Focus: A Look at Combination Products
    • The Printed World: Additive Manufacturing in Medtech
    • The Lost Year: 2020 Year in Review
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Brown Fat Associated with Reductions in Chronic Disease Risk
    NIH Study Identifies Antibacterial Properties in Taurine
    NSF Begins New Certification Program
    Coatings World

    Latest Breaking News From Coatings World

    Zeppelin Acquires MTI Mischtechnik
    Ezio Braggio Joins ChemQuest Europe
    IFS Coatings Announce Carbon Offset Program
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Optimize EP Launches CaRM Cardiac Device Data Management Platform
    U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030
    FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR
    Contract Pharma

    Latest Breaking News From Contract Pharma

    KORSCH, MEDELPHARM Partner on R&D Equipment Portfolio
    Frontage Bolsters Clinical Services Capabilities
    Sanofi Unveils EUROAPI as Name of New European API Company
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Neenah to Host Packaging Webinar for Printers
    W.S. Badger is Named a ‘150 Top Impact Company’
    Mana Products, Meiyume and RPG Form The Vertical Beauty Alliance
    Happi

    Latest Breaking News From Happi

    A Surge in Interest for Supplements & Vitamins
    P&G, L'Oréal & Amorepacific Make News at CES
    Three Form Vertical Beauty Alliance
    Ink World

    Latest Breaking News From Ink World

    dar-tech, inc. Becomes U.S. Midwestern Distributor for ZS Interpolymer
    Techkon USA, Konica Minolta Partner
    Alon Bar-Shany Appointed Chairman of Highcon Board
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Exhibitor registration opens for virtual.drupa
    FTA planning in-person Forum & INFOFLEX
    Fortis Solutions Group achieves SGP certification
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Shemesh Adds U.S. Headquarters
    TZMO USA, Special Needs Group Form Partnership
    BAHP Announces 2021 Officers, Board of Directors
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Rapid Recovery Protocol Can Lead to Increased Range of Motion After TKA
    Boston Scientific Releases WaveWriter Alpha Spinal Cord Stimulators in U.S.
    New Chief Clinical Officer on Board at IncludeHealth
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Roadsimple Modernizes Warehouse Ops with Zebra Technologies
    Toppan Announces 2050 Environmental Vision
    SOI Industry Consortium Joins SEMI as Strategic Association Partner

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login