• 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
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    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
    Regulatory
    Financial/Business
    Top News
    MPO's Most-Read Stories This Week—July 2

    OmniGuide Awarded FDA Clearance for RevoLix Hybrid Thulium Laser

    Pancryos Forges License Agreement for Microencapsulation Device

    FDA Awards IDE Approval to SELUTION SLR Drug-Eluting Balloon

    Matt Rainville Joins Bigfoot Biomedical as Chief Commercial Officer
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Theranos Fraud Trial, Part II: The Blame Game Continues

    An Update on Surgical Robotics

    Letting the Light In: How Failure Analysis is the Cornerstone of Success

    Three Talent Strategies to Attract High-Demand Skills

    The Advantages of Bioburden Screening for Sterilization Validation
    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
    Concise Engineering

    Fusion Biotec Inc.

    Xact Wire EDM Corp.

    Cirtec Medical

    BMP Medical
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    ‘Right to Repair’: Separating Fact from Fiction

    Taking a Holistic Approach to Decentralized Clinical Trials (DCTs)

    Investment in Health Startups Drops

    The Power of Leveraging Customer Relationships

    Cost Effective & Efficient Wire EDM Techniques
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Concise Engineering

    Fusion Biotec Inc.

    Xact Wire EDM Corp.

    Cirtec Medical

    BMP Medical
    • 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
    • eBook
    • Resources
    • Podcasts
    • 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

    FDA Commissioner Declares New Steps to Advance Medical Device Innovation

    FDA efforts also aim to help patients gain faster access to beneficial technologies.

    Related CONTENT
    • Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles
    • Accu-Tube Appoints Matthew Haddle as CEO
    • Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings
    • CE Mark Granted to Predictive Software for Kidney Allograft Survival
    • Electroducer Raises 3 Million Euros to Market Heart Valve Disease Tech
    U.S. Food and Drug Administration10.25.17
    Enabling patients and providers to have efficient access to new and innovative medical products that meet the FDA’s gold standard for safety and effectiveness is a core part of our mission. We’re advancing these goals as part of the Medical Innovation Access Plan that I announced earlier this year. While we’ve unveiled parts of that plan already, we’ll be releasing its full detail shortly. As one part of that effort, we’re announcing some additional steps we’re taking right now to promote beneficial medical device innovation.
     
    Medical device technology evolves quickly. The process for improving the performance and clinical characteristics of medical devices is highly iterative. Often it’s the case that small modifications help provide incremental but meaningful improvements to products. Over time, these cumulative advances are consolidated into more noticeable advances in the performances of different technologies. Therefore it’s important for the FDA to enable innovators to have the flexibility to efficiently make these kinds of small modifications. At the same time, the FDA needs to establish modern tools and benchmarks for measuring the safety and performance of devices to make sure they’re delivering the expected benefits to patients.
     
    We’re taking several new steps toward each of these goals.
     
    First, we’ve completed our first qualification of a medical device development tool (MDDT) to provide a more objective platform for developing devices in a key area of medicine—cardiovascular health. Fostering the creation and validation of development tools that can be used to provide more efficient and accurate ways to measure risk and benefit, as part of the medical product development process, is a key goal of the FDA. At the FDA, we’re undertaking a comprehensive policy effort to facilitate the development and validation of these kinds of medical device development tools.
     
    The newly qualified MDDT is a 23-item questionnaire that measures health information that is reported directly by patients with heart failure. The tool can be used to measure a heart failure patient’s health status, including clinical symptoms and the physical and social limitations caused by this condition. Such a tool has the potential to help engineers designing heart failure devices to more efficiently and accurately quantify how much their device could actually improve a patient’s quality of life. By qualifying the tool under the FDA’s new, voluntary program, it will make it easier for product developers to rely on the outputs of this newly qualified tool as part of their development plans. Innovators can trust in advance that the agency has already found the outputs of these measures to be reliable.
     
    We expect to evaluate and qualify more medical device development tools in the coming months, and we encourage this kind of product development. One area in which there may be an opportunity is wearable technologies. These tools have the potential to provide fundamentally better ways of measuring clinical outcomes, like how a device or even a drug affects outcomes that relate to physical performance or the function and output of different organ systems. The development of more modern tools for measuring outcomes relevant to regulatory decisions is a key part of our efforts to promote innovation. Such development tools can also help minimize the use of animal studies, reduce the duration of testing, or require fewer patients in a study by optimizing patient selection or improving on the ability to measure benefit and risk through the availability of measurements that are more sensitive for assessing these outcomes. FDA experts from the agency’s Center for Devices and Radiological Health issued a blog on this important program.
     
    To make the development process more efficient and predictable, the FDA is also releasing three new guidance documents related to medical devices. The first is a draft guidance delineating the FDA’s new “Breakthrough Devices Program,” which was created by the 21st Century Cures Act passed by Congress last year. Building on the Expedited Access Pathway (EAP) program, this new program is intended to help patients more quickly access certain devices that more effectively diagnose or treat life-threatening or irreversibly debilitating diseases or conditions, such as technologies that have no alternative or that offer a significant advantage over FDA-cleared or approved alternatives. The program described in the draft guidance would enable a more agile pre-submission process for breakthrough devices. Breakthrough device innovations that are highly novel can also be more complex to assess. Thus, earlier and more frequent interaction between the FDA and manufacturers—as outlined in our draft guidance on the Breakthrough Device Program—should allow manufacturers to make the best use of their resources to bring state-of-the-art medical technologies to the market faster.
     
    Another two final guidances will help innovators determine when they need to submit a new 510(k) prior to making a change to a legally-marketed device subject to premarket notification (510(k)) requirements. These policies will help innovators introduce iterative improvements that can improve a product’s safety and performance by establishing a brighter line regarding when the FDA needs to review and clear these changes in advance.
     
    These new guidance documents do not change the FDA’s review standard: A new 510(k) is required when a marketed device has changes, including changes to software, that could significantly affect the safety or effectiveness of the device or when there are major changes in the intended use of the device. Instead, the new policies enhance predictability and consistency for innovators deciding when to submit new 510(k)s by better describing the regulatory framework, policies and practices underlying such a decision.
     
    This improved clarity will help lower the barriers to innovation and improve patient care by reducing unnecessary submissions to the FDA for changes that could not significantly affect device safety or effectiveness, so patients can benefit from upgraded products more quickly. Many devices function as tools in the hands of physicians. They benefit from feedback from doctors that helps innovators make small adaptations to improve a device’s performance. A regulatory framework that fosters this kind of useful revision is a key to improving their safety and performance.
     
    These are just some of the steps we’re taking to encourage innovation in medical devices. The FDA will be unveiling additional steps we’ll take to improve the path for device innovation while building additional safeguards to ensure the safety and effectiveness of new and existing products.
     
    The FDA’s effort to promote the creation and regulatory acceptance of development tools also encompasses efforts across the agency’s drug programs. With the passage of the 21st Century Cures legislation, the biomarker and Clinical Outcome Assessment qualification programs are now formalized and have the added benefit of key features that will promote the development of these innovative tools for a specified context of use to aid in promoting efficiency in drug development. The legislation emphasizes the importance of partnering with external stakeholders, increases transparency and predictability, and allows for prioritization of projects that will have the greatest public health impact. In addition to qualification efforts, a new work stream has been developed to design and validate a series of algorithms (as drug development tools) that can be used for simulations to predict an outcome such as overall survival once key patient and disease parameters are entered into the model. These approaches can be used for classification of important observations made in clinical trials, such as assessment of tumor growth versus shrinkage.
     
    The aim of all of these policies is to improve patient access to innovative medical products while continuing to protect those who rely on these products.
    Related Searches
    • medical device
    • testing
    • assessment
    • health
    Suggested For You
    Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles
    Accu-Tube Appoints Matthew Haddle as CEO Accu-Tube Appoints Matthew Haddle as CEO
    Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings
    CE Mark Granted to Predictive Software for Kidney Allograft Survival CE Mark Granted to Predictive Software for Kidney Allograft Survival
    Electroducer Raises 3 Million Euros to Market Heart Valve Disease Tech Electroducer Raises 3 Million Euros to Market Heart Valve Disease Tech
    Precision Coating Merges with N2 Biomedical Precision Coating Merges with N2 Biomedical
    Medical Devices Market to Top $671.49 Billion by 2027 Medical Devices Market to Top $671.49 Billion by 2027
    Indago Announces $10 Million Financing Close and Name Change Indago Announces $10 Million Financing Close and Name Change
    Molli Surgical Molli Surgical's Breast Tumor Marker
    Vertigo Treatment Receives FDA Breakthrough Device Designation Vertigo Treatment Receives FDA Breakthrough Device Designation
    RapidPulse Closes $15 Million Series A Financing RapidPulse Closes $15 Million Series A Financing
    Midwest Products & Engineering Acquires MindFlow Design Midwest Products & Engineering Acquires MindFlow Design
    Vicarious Surgical Opens New Corporate Headquarters in Massachusetts Vicarious Surgical Opens New Corporate Headquarters in Massachusetts
    Luis J. Malavé Joins Integrity Applications Board Luis J. Malavé Joins Integrity Applications Board
    Stryker Buys Gauss Surgical Stryker Buys Gauss Surgical

    Related Breaking News

    • Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles

      Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles

      Neela Paykel is serving as general counsel and Tom Teisseyre assumes the chief product officer position.
      Business Wire 09.22.21

    • Tubing & Extrusion
      Accu-Tube Appoints Matthew Haddle as CEO

      Accu-Tube Appoints Matthew Haddle as CEO

      Haddle has a track record of leading organizations through strategic expansions across the medical device, aerospace, and industrial sectors.
      Accu-Tube 09.22.21

    • Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings

      Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings

      The two deals will strengthen Heraeus' healthcare and medtech portfolio.
      Heraeus 09.22.21


    • CE Mark Granted to Predictive Software for Kidney Allograft Survival

      CE Mark Granted to Predictive Software for Kidney Allograft Survival

      Algorithm gives the probability the graft will still be functional at three, five, and seven years after evaluation by a healthcare professional.
      Cibiltech 09.21.21

    • Electroducer Raises 3 Million Euros to Market Heart Valve Disease Tech

      Electroducer Raises 3 Million Euros to Market Heart Valve Disease Tech

      Electroducer Sleeve based on a medical technique called Direct Wire Pacing, which was invented by the company’s founder.
      Electroducer 09.21.21

    Loading, Please Wait..

    Trending
    • How To Overcome The Top 6 Medical Device Manufacturing Challenges
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • AI-Enabled SKOUT Device Improves Colorectal Cancer Screening
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • 7 Steps To Create Your Own Medical Device Marketing Plan
    Breaking News
    • MPO's Most-Read Stories This Week—July 2
    • OmniGuide Awarded FDA Clearance for RevoLix Hybrid Thulium Laser
    • Pancryos Forges License Agreement for Microencapsulation Device
    • FDA Awards IDE Approval to SELUTION SLR Drug-Eluting Balloon
    • Matt Rainville Joins Bigfoot Biomedical as Chief Commercial Officer
    View Breaking News >
    CURRENT ISSUE

    June 2022

    • OEMs Seek Molders Offering Timely Techniques
    • Robotic Surgery: Cutting Through to the Latest
    • Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    • 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

    Pharmavite Expands in Ohio with $200 Million Investment
    Nestlé Health Science Expands in New Zealand with Deal to Buy The Better Health Company
    Younger Consumers Drive Growing Demand for Ingestible Beauty and Skin Care Products
    Coatings World

    Latest Breaking News From Coatings World

    Azelis Acquires Chemical Partners, Strengthens Leadership in Africa and Middle East
    Emmanuelle Bromet Named Arkema Sustainable Development VP
    ROSS Planetary Dual Dispersers Have Unique Processing Flexibility
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most-Read Stories This Week—July 2
    OmniGuide Awarded FDA Clearance for RevoLix Hybrid Thulium Laser
    Pancryos Forges License Agreement for Microencapsulation Device
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Bayer Opens New Research and Innovation Center at Kendall Square
    Lonza Names Maria Soler Nunez as Head, Group Operations
    Eurofins DiscoverX Opens Shanghai Office
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Dexlevo Introduces Beauty Treatment technique, ‘GOURI’
    Revision Skincare Exec Wins Ernst & Young Entrepreneur of the Year
    Latest Updates About Cosmoprof North America
    Happi

    Latest Breaking News From Happi

    L’Oréal’s Solution for Gray Hair, Scotch Porter's New President & Boots No. 7 Beauty Is Not for Sale
    SCOTUS EPA Ruling Won’t Impact General Regulatory Authority
    Toning Collection For Zero-Brass Blondes is New at Colorproof
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: Flint OPS, Xerox and MNYPIA Top This Week’s News
    Azelis Acquires Chemical Partners, Adds to Leadership in Africa and Middle East
    International Paper Publishes 2021 Sustainability Report
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    UPM Raflatac boosts operations in US, All4Labels returns to HP and more
    Fedrigoni Self-Adhesives to exhibit at Labelexpo Americas for first time
    CELAB Europe wins Paper Recycling award
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Weekly Recap: Lifetime Technical Achievement Award Presented to Richard Knowlson, Alkegen Completes Luyang Acquisition & More
    Glatfelter, Blue Ocean Closures Partner with Absolut
    What You’re Reading on Nonwovens-Industry.com
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—July 2
    NuVasive Inc. Opens Singapore Experience Center
    Pedicle Screw Systems Market to Top $3B in 2027
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: eMagin, Identiv, and Japan Display Top This Week’s Stories
    Epishine is Building a New Solar Cell Factory in Linköping, Sweden
    Toppan Establishes CVC Fund and Investment Management Company in the US

    Copyright © 2022 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