• 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
    Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts

    Digitize Your QMS via an Enterprise Cloud Platform

    Diagnostic Desperation: A Look at IVD Trends During COVID-19

    Resourceful Resources: Materials Make a Difference During the Pandemic

    Stressed Testing: Challenges with Medical Device Testing
    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
    Cretex CFO Announces Retirement

    New AI-Based Tool Developed for Coronary Artery Analysis, Intervention Planning

    First Reported Use of Pulse Biosciences' CellFX System

    EUA Granted for New COVID-19, Flu A, Flu B Combo Kit

    EchoNous Expands Its Kosmos Hardware Platform
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts

    Digitize Your QMS via an Enterprise Cloud Platform

    Diagnostic Desperation: A Look at IVD Trends During COVID-19

    Resourceful Resources: Materials Make a Difference During the Pandemic

    Stressed Testing: Challenges with Medical Device Testing
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Cybersecurity Compromises, Courtesy of COVID-19

    A Look at the Actual Device Costs for Hospitals

    Show Time: Here’s What a Year of No Tradeshows Meant for Small Businesses

    FDA Making Progress With Technology and Data Action Plans

    What’s Hot Now in Medtech M&A
    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
    FUTEK Advanced Sensor Technology Inc.

    Qosina Corp.

    Creganna Medical, part of TE Connectivity

    PTI Engineered Plastics Inc.

    Medicoil
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How Grant Funding Works and How It Can Help

    Refurbished Medical Equipment Testing and Certification Under the NEC

    Taking the First Step with Metal Components

    4 Trends Driving Medical Manufacturing in 2021

    Pioneering AI Solutions to Reinforce Healthcare Services
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Medbio LLC

    FUTEK Advanced Sensor Technology Inc.

    Unicep

    PTI Engineered Plastics Inc.

    Spectrum Plastics Group
    • 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

    Latest Steps to Strengthen FDA’s 510(k) Program for Premarket Review

    The 510(k) program must keep pace with the important innovations FDA is seeing in device development.

    Related CONTENT
    • 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
    • FDA Clears Scientia Vascular's Zoom Wire
    Scott Gottlieb, M.D., Commissioner; Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health;, U.S. Food and Drug Administration01.23.19
    In 2018, the FDA’s Center for Devices and Radiological Health achieved several new milestones, including a record-setting year for approvals of novel medical devices. We also focused on advancing several meaningful initiatives and policy proposals aimed at enhancing the safety of medical devices, including the safety of devices cleared through the FDA’s 510(k) review process.
     
    We articulated those concepts early in the year as part of the FDA’s Medical Device Safety Action Plan and most recently with our announcement of changes to strengthen the 510(k) program. The Safety Action Plan described actions we’ve taken over the past several years to enhance device safety and outlined our vision for how the agency can build on these initiatives to further assure the safety and effectiveness of medical devices.
     
    As we start the new year, we’re dedicated to executing on the commitments we laid out last year and implementing our proposed new policies. As we outlined this past November, one of our goals is to ensure that the 510(k) program is keeping pace with the important innovations we’re seeing in device development. We believe this means that, where appropriate, new medical devices coming to market under the 510(k) pathway should either account for advances in technology that can improve the safety or performance of these products, or demonstrate that they meet more modern safety and performance criteria. Today, we’re pleased to announce two developments toward advancing this policy effort.
     
    First, the FDA posted its final guidance establishing the framework for the Safety and Performance Based Pathway1. The new name for this guidance reflects our focus on advancing new products with improved safety and performance. This option for 510(k) clearance will modernize our approach to moderate risk devices by allowing manufacturers to use objective performance criteria established or recognized by the FDA to facilitate demonstration of substantial equivalence of their new products to legally marketed devices. Under the traditional approach, manufacturers often rely on comparative testing against a device already on the market, known as a predicate device, to show that a new device is as safe and effective as the predicate device. But, the predicates may be older and, consequently, they may not reflect the modern technology embedded in new devices of that type.
     
    For appropriate device types, the Safety and Performance Based Pathway will ensure that the performance characteristics of new devices are evaluated against a set of objective, transparent and well-validated safety and performance metrics. It’s important to note that devices using this pathway will still have to meet our current standards for reasonable assurance of safety and effectiveness before they can be marketed. The benefit of this approach is that the pathway will benchmark modern technology against modern standards while, at the same time, offering a potentially more efficient way to demonstrate that a new device is substantially equivalent to devices already on the market, and thereby ensure patients have timely access to beneficial products. We also believe this new approach may drive greater market competition to develop safer devices. By using this pathway, manufacturers would have demonstrated that their products meet objective safety and performance criteria that are based on modern technological principles.
     
    This year, we’ll build on today’s final guidance by establishing safety and performance criteria for certain well-understood device types. We’ll issue these criteria through guidance, which includes an opportunity for public comment prior to using them under the new pathway.

    In addition, today, the FDA is soliciting public comment on steps that we could take to further encourage medical device manufacturers to develop innovations that enhance the safety of 510(k) devices. One possible way to advance this goal could be to focus on the use of more modern predicate devices.
     
    As we noted above, older predicates might not closely reflect modern technology used in new devices. While this doesn’t mean the products that reference those predicates are unsafe, it does mean there is an opportunity to examine how we can enhance the process to ensure devices are continually improving so patients can reap the benefits of modern advancements.
     
    To that end, as we discussed in our November statement, we’re considering whether, in addition to the information in the 510(k) database, the FDA should post on its website a list of FDA-cleared devices that demonstrated substantial equivalence to older predicate devices. Doing so would create more transparency about these technologies, with the goal of driving device manufacturers to offer patients devices with the latest improvements.
     
    However, we recognize that for some types of well-established technologies there is not a need for improvements, and reliance on older predicates would not only be appropriate but necessary. We’re seeking comment on this new proposed approach, as well as other questions that will help inform our regulatory policy development, including:
     
    • Should the FDA make public a list of devices, or manufacturers who make technologies, that rely on predicates that have been on the market for more than a certain number of years (e.g., 10 years)? If so, what would be an appropriate period of time?
    • Should the FDA consider using other criteria to inform our point of reference?
    • Are there other and/or alternative actions we should take to promote the development and marketing of safer, more effective 510(k) devices?
    • Should the FDA consider certain actions that might require new authority, such as making at least some older devices ineligible as predicates?
     
    The FDA has opened a docket to receive comment on these questions, and we request that any responses be provided within 90 days. We’re committed to engaging with the public on our approach to 510(k) modernization and look forward to receiving and reviewing this feedback.
     
    We believe firmly in the merits of the 510(k) process. Thousands of devices are cleared through this process each year and countless thousands more patients benefit from these technologies. In taking these new steps today, we’re reaffirming our commitment to continually strengthening our review process, so that it can continue to serve and protect American patients well for years to come.
     
    Reference
    1 Guidance previously titled “Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria.”
    Related Searches
    • regulatory
    • standards
    • it
    • health
    Suggested For You
    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
    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
    FDA OKs Minnetronix FDA OKs Minnetronix's MindsEye Neurosurgical Access Platform
    FDA Clears KA Imaging’s Portable Dual-Energy X-Ray Detector FDA Clears KA Imaging’s Portable Dual-Energy X-Ray Detector

    Related Breaking News

    • Cretex CFO Announces Retirement

      Cretex CFO Announces Retirement

      Scott Lunger will succeed Steve Ragaller as CFO.
      Charles Sternberg, Assistant Editor 03.05.21

    • Digital Health
      New AI-Based Tool Developed for Coronary Artery Analysis, Intervention Planning

      New AI-Based Tool Developed for Coronary Artery Analysis, Intervention Planning

      Deep learning (DL) algorithms are combined with classic computer vision methods to create a 3D model of the coronary arteries.
      Michael Barbella, Managing Editor 03.05.21

    • First Reported Use of Pulse Biosciences

      First Reported Use of Pulse Biosciences' CellFX System

      The product represents an advanced, next-generation modality for dermatology procedures addressing common skin conditions.
      Michael Barbella, Managing Editor 03.05.21


    • Diagnostics
      EUA Granted for New COVID-19, Flu A, Flu B Combo Kit

      EUA Granted for New COVID-19, Flu A, Flu B Combo Kit

      One multiplex real-time PCR diagnostic kit can simultaneously detect and differentiate SARS-CoV-2, influenza A and influenza B.
      Michael Barbella, Managing Editor 03.05.21

    • Diagnostics
      EchoNous Expands Its Kosmos Hardware Platform

      EchoNous Expands Its Kosmos Hardware Platform

      Adds continuous wave and pulsed wave Doppler capabilities.
      Charles Sternberg, Assistant Editor 03.04.21

    • Cardiovascular
      Medtronic Begins Trial to Assess Novel Ablation Tech to Treat AFib

      Medtronic Begins Trial to Assess Novel Ablation Tech to Treat AFib

      Will evaluate PulseSelect's pulsed electrical fields to interrupt irregular heart rhythms.
      Sam Brusco, Associate Editor 03.04.21


    • Europe

      Europe's Cross-Border Medtech Deal Activity Rises in Q4 2020

      M&A was the most prolific of deal types.
      Michael Barbella, Managing Editor 03.04.21

    • Chronic Disease | Diagnostics
      Bio-Techne to Acquire Asuragen for $320M

      Bio-Techne to Acquire Asuragen for $320M

      Bio-Techne gains genetic carrier screening and oncology testing kits.
      Sam Brusco, Associate Editor 03.04.21

    • QUANTA Appoints Chief Operating Officer

      QUANTA Appoints Chief Operating Officer

      New executive has 15 years of experience, including a stint at Johnson & Johnson Medical Devices & Diagnostics.
      Michael Barbella, Managing Editor 03.04.21


    • BD Buys GSL Solutions to Broaden Medication Management

      BD Buys GSL Solutions to Broaden Medication Management

      GSL develops smart medication devices to store and track controlled substances.
      Sam Brusco, Associate Editor 03.04.21

    • Philips Partners With AI Software Provider for Better Workflow

      Philips Partners With AI Software Provider for Better Workflow

      The company will incorporate Lunit's chest detection suite into its diagnostic X-ray platform.
      Michael Barbella, Managing Editor 03.04.21

    • Plastikos Medical Begins Phase II of Expansion

      Plastikos Medical Begins Phase II of Expansion

      Will more than double the size of its current ISO-7 cleanroom.
      Charles Sternberg, Assistant Editor 03.03.21


    • Ready Robotics Hires Proven Automation Leaders

      Ready Robotics Hires Proven Automation Leaders

      Juan Aparicio and Mark Patterson join the company.
      Charles Sternberg, Assistant Editor 03.03.21

    • Diagnostics | Digital Health
      Philips, Disney Join Forces to Reduce Childrens

      Philips, Disney Join Forces to Reduce Childrens' MRI Anxiety

      Will explore effects and use of animated stories and characters, including Disney favorites, as part of Philips Ambient Experience solution.
      Sam Brusco, Associate Editor 03.03.21

    • Surgical
      FDA OKs Asensus

      FDA OKs Asensus' Senhance for General Surgery

      Indication expansion allows Senhance's use in high-value, complex reconstructive surgeries.
      Sam Brusco, Associate Editor 03.03.21


    Trending
    • Plastikos Medical Begins Phase II Of Expansion
    • Hardy Diagnostics Releases Rapid Test For COVID-19
    • FDA Clears ENvizion's Personalized Feeding Tube Placement Device
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Cheetah Medical Introduces Noninvasive Monitoring System
    Breaking News
    • Cretex CFO Announces Retirement
    • New AI-Based Tool Developed for Coronary Artery Analysis, Intervention Planning
    • First Reported Use of Pulse Biosciences' CellFX System
    • EUA Granted for New COVID-19, Flu A, Flu B Combo Kit
    • EchoNous Expands Its Kosmos Hardware Platform
    View Breaking News >
    CURRENT ISSUE

    March 2021

    • Stressed Testing: Challenges with Medical Device Testing
    • Resourceful Resources: Materials Make a Difference During the Pandemic
    • Diagnostic Desperation: A Look at IVD Trends During COVID-19
    • Digitize Your QMS via an Enterprise Cloud Platform
    • Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts
    • 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

    Thymoquinone Inhibits Viral Infection in In Vitro Settings, New Study Finds
    IFT Transitions 2021 Annual Event to Digital Experience
    NY Federal Judge Enters Permanent Injunction Against Dietary Supplement Manufacturer
    Coatings World

    Latest Breaking News From Coatings World

    Sherwin-Williams Announces Resignation of President, COO
    Ashland Completes Expansion, Relocation of Viatel Bioresorbable Polymers Manufacturing Facility
    Evonik Receives Sustainability Award from EcoVadis
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Cretex CFO Announces Retirement
    New AI-Based Tool Developed for Coronary Artery Analysis, Intervention Planning
    First Reported Use of Pulse Biosciences' CellFX System
    Contract Pharma

    Latest Breaking News From Contract Pharma

    AGC Biologics Expands Cell and Gene Facility in Italy
    Celonic to Boost Cell & Gene Therapy Production
    Pharmaron Acquires Biomanufacturing Site in the UK from AbbVie
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Ulta Beauty Opens in Herald Square
    Elizabeth Arden Taps Sui He as Global Brand Ambassador
    Natura &Co Outperforms the Global Market in Q4 2020
    Happi

    Latest Breaking News From Happi

    What You're Reading on Happi.com
    Indie Beauty Innovators Wanted
    Cosmetic Chemists Seek Mentors
    Ink World

    Latest Breaking News From Ink World

    Massilly North America Adds Koenig & Bauer MetalStar 3 Metal Decorating Press
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Access Direct Mail Doubles Revenue with SCREEN's Truepress Jet520HD
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Arjobex America welcomes Maggie Naberezny to sales team
    Henkel publishes 30th Sustainability Report
    Avery Dennison Smartrac launches new Circus Pro inlays
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    FPInnovations Develops Biodegradable Mask
    Sani Professional Sanitizing and Disinfecting Products Approved by EPA
    Autefa Solutions Offers Fully Automated Line for Protective Mask Production
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Colfax Decides to Divide Its Businesses
    Stryker Corp.'s 2020 Sales Slip 3.6 Percent
    Bioventus Appoints Managing Director, China and Asia Pacific
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Smart Glass Market to Register 6.8% CAGR Between 2021-28: Grand View Research
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027

    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