• 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
    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability

    Machining & Laser Processing Have Huge Parts to Play in Medtech Manufacturing

    Medtech R&D Teams Must Be Creative & Resilient to Survive

    Struggling Suppliers in Electronics Manufacturing Services (EMS)

    Deep (Brain) Thoughts with Medtronic's Neuromodulation President
    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
    PDC Unveils New Brand Identity

    MD&M West News: Teamvantage Launches New Parent Company

    BD Receives EUA from FDA for COVID-19, Influenza A/B, RSV Combination Test

    Qosina Names Lee Pochter as Executive Vice President

    FDA Okays Early Feasibility Study for Anteris' TAVR Product
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability

    Machining & Laser Processing Have Huge Parts to Play in Medtech Manufacturing

    Medtech R&D Teams Must Be Creative & Resilient to Survive

    Struggling Suppliers in Electronics Manufacturing Services (EMS)

    Deep (Brain) Thoughts with Medtronic's Neuromodulation President
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Deducing the Dual Reality of Elizabeth Holmes

    The Return of the AdvaMed MedTech Conference…Live!

    Material Matters: New Materials Call for New Thinking

    5 Ways to Maintain a Talent-Centric Mindset, Even During Economic Uncertainty

    The Changing Face of UK Medical Device Regulations: Most Recent Update
    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
    Providence Enterprise USA Inc.

    JBC Technologies

    Forefront Medical Technology

    Fusion Biotec Inc.

    Arthur G. Russell Co. Inc., The
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Onshoring Medical Device Manufacturing Can Strengthen Supply Chains

    How Artificial Intelligence Can Combat Key Issues Impacting Healthcare

    Why Advanced Sensors Are Crucial Within Medical Pumps

    How Artificial Intelligence Could Help Prevent 80% of Chronic Diseases

    4 Ways to Use Injection Molding in Medical Device Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Providence Enterprise USA Inc.

    JBC Technologies

    Forefront Medical Technology

    Fusion Biotec Inc.

    Arthur G. Russell Co. Inc., The
    • 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

    AdvaMed’s Whitaker Urges Congressional Action on MDUFA

    Stresses the need for Congress to move forward with agreement between FDA and industry.

    AdvaMed’s Whitaker Urges Congressional Action on MDUFA
    Related Content
    • Is Your Biocompatibility Program on the Edge?
    • New 510(k) Approach Would Leverage FDA Objective Criteria
    • FDA Clears CrossBay Medical's IVF Embryo Transfer Catheter Set
    • AdvaMed Unveils Frameworks for Assessing Value of MedTech and Diagnostics
    • FDA Approval for Medtronic’s MR-Conditional Quadripolar CRT-Pacemakers
    Advanced Medical Technology Association04.04.17
    Advanced Medical Technology Association (AdvaMed) president and CEO Scott Whitaker testified before the Senate HELP Committee today on reauthorization of the Medical Device User Fee Act (MDUFA), stressing the urgent need for Congress to move forward with the agreement as negotiated between FDA and industry.
     
    “The MDUFA IV agreement lays the groundwork to build on recent FDA performance improvements through more ambitious goals, important process changes and increased accountability, supported by additional resources,” Whitaker said.
     
    “We strongly support the vital improvements made by the new agreement and believe that a failure to act would have a destructive impact on our industry’s ability to bring new, innovative treatments, diagnostics and cures to patients,” he cautioned.
     
    While focusing on the benefits of the negotiated MDUFA agreement for patients, FDA and innovation, Whitaker noted that there were additional legislative reforms Congress could consider outside the parameters of the negotiated agreement to “enhance and compliment the underlying user fee agreement” that will “maximize[s] the opportunity for success at the agency, which should be the shared goal of all involved.”
     
    As one example, he cited bipartisan legislation recently introduced in both the House and Senate that designed to improve the consistency and transparency of FDA inspections and to move to a risk-based system for inspections. “These common-sense proposals will ensure that FDA’s inspections resources are best targeted to public health needs and that companies and FDA are working together,” Whitaker said.
     
    He called on the Senate HELP Committee and its counterparts in the House to “act promptly to reauthorize this program, which is so critical to our industry, to the FDA, and to patients.”
     
    A copy of Whitaker’s written testimony can be viewed here.
    Related Searches
    • legislation
    • fda
    • diagnostics
    • medical
    Suggested For You
    Is Your Biocompatibility Program on the Edge? Is Your Biocompatibility Program on the Edge?
    New 510(k) Approach Would Leverage FDA Objective Criteria New 510(k) Approach Would Leverage FDA Objective Criteria
    FDA Clears CrossBay Medical FDA Clears CrossBay Medical's IVF Embryo Transfer Catheter Set
    AdvaMed Unveils Frameworks for Assessing Value of MedTech and Diagnostics AdvaMed Unveils Frameworks for Assessing Value of MedTech and Diagnostics
    FDA Approval for Medtronic’s MR-Conditional Quadripolar CRT-Pacemakers FDA Approval for Medtronic’s MR-Conditional Quadripolar CRT-Pacemakers
    Industry Offers Support for Gottlieb Confirmation Industry Offers Support for Gottlieb Confirmation
    FDA Approves First First Flexible Shaver for Interventional Gastroenterology FDA Approves First First Flexible Shaver for Interventional Gastroenterology
    Hospitals Looking to Medtech for Stronger Alliances Hospitals Looking to Medtech for Stronger Alliances
    FDA Clears Samsung FDA Clears Samsung's Digital Radiography System
    FDA Designates Medtronic Action as Class I Recall FDA Designates Medtronic Action as Class I Recall
    FDA Clears First Portable Unified Respiratory System for Patients on a Ventilator FDA Clears First Portable Unified Respiratory System for Patients on a Ventilator
    The Tax that Wouldn’t Die The Tax that Wouldn’t Die
    FDA Clears ETS Wound Care FDA Clears ETS Wound Care's Advanced Wound Matrix
    Senate Bill Would Improve Medicare LCD Process Senate Bill Would Improve Medicare LCD Process
    AdvaMed Urges Device Tax Repeal AdvaMed Urges Device Tax Repeal

    Related Online Exclusives

    • Testing
      Is Your Biocompatibility Program on the Edge?

      Is Your Biocompatibility Program on the Edge?

      Regulatory changes in both Europe and the U.S. have created uncertainty among device makers.
      Thor Rollins, B.S., RN (NRCM), Senior Scientist, Nelson Laboratories 05.18.17

    • New 510(k) Approach Would Leverage FDA Objective Criteria

      New 510(k) Approach Would Leverage FDA Objective Criteria

      AdvaMed president issues statement in support of new legislation.
      Advanced Medical Technology Association 05.18.17

    • FDA Clears CrossBay Medical

      FDA Clears CrossBay Medical's IVF Embryo Transfer Catheter Set

      The device has also received clearance to commercialize the product in Europe by obtaining its CE mark.
      PR Newswire 05.18.17


    • AdvaMed Unveils Frameworks for Assessing Value of MedTech and Diagnostics

      AdvaMed Unveils Frameworks for Assessing Value of MedTech and Diagnostics

      Association collaborates with Deloitte to spark dialogue among all healthcare stakeholders.
      Advanced Medical Technology Association 05.16.17

    • Cardiovascular
      FDA Approval for Medtronic’s MR-Conditional Quadripolar CRT-Pacemakers

      FDA Approval for Medtronic’s MR-Conditional Quadripolar CRT-Pacemakers

      Portfolio of heart failure devices offers effective pacing and access to the most advanced diagnostic imaging procedures.
      Medtronic plc 05.11.17

    Loading, Please Wait..

    Trending
    • The Future Of Biomedical Engineering Advancements
    • MO SCI Acquires Assets Of 3M’s Advanced Materials Business
    • CGM Devices Could Become Main Glucose Monitoring Solution In U.S.
    • Endologix Shares Positive 12-Month Results Of DETOUR-2 Trial
    • FDA Okays Early Feasibility Study For Anteris' TAVR Product
    Breaking News
    • PDC Unveils New Brand Identity
    • MD&M West News: Teamvantage Launches New Parent Company
    • BD Receives EUA from FDA for COVID-19, Influenza A/B, RSV Combination Test
    • Qosina Names Lee Pochter as Executive Vice President
    • FDA Okays Early Feasibility Study for Anteris' TAVR Product
    View Breaking News >
    CURRENT ISSUE

    January/February 2023

    • Struggling Suppliers in Electronics Manufacturing Services (EMS)
    • Machining & Laser Processing Have Huge Parts to Play
    • Medtech R&D Teams Must Be Creative & Resilient to Survive
    • Medtronic Neuromodulation President, Nnamdi Njoku, Interview
    • 6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability
    • 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

    Tocotrienols May Have Protective Effect on Liver in NAFLD Patients
    Indian Gooseberry Extract Shown to Offer Blood Sugar Management Benefits
    ADM Expands Production to Meet Demand for Probiotics
    Coatings World

    Latest Breaking News From Coatings World

    AkzoNobel Reports Revenue Growth in 2022
    Orion Engineered Carbons Announces New Distribution Partnerships
    Personnel Changes at BASF
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    PDC Unveils New Brand Identity
    MD&M West News: Teamvantage Launches New Parent Company
    BD Receives EUA from FDA for COVID-19, Influenza A/B, RSV Combination Test
    Contract Pharma

    Latest Breaking News From Contract Pharma

    KORSCH Acquires MEDELPHARM to Strengthen R&D Product Line
    SRI Names Kathlynn Brown Biosciences Division President
    Battelle, AmplifyBio, Andelyn Biosciences Win Research Contract
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Kiss Colors & Care Taps Rapper JT as Brand Partner
    Revolution Beauty Expands into Walmart in the U.S.
    Macro-Environmental Factors Impacting the Packaging Industry
    Happi

    Latest Breaking News From Happi

    Perfect Corp. Receives MLPS 2.0-Compliant Status to Help Beauty and Fashion Brands Meet China's National Cybersecurity Standards
    Ocean Conservation Managers Convene for Fifth International Marine Protected Area Congress, Receives Private Sector Support From Mary Kay Inc.
    Mintel Reveals Macro-Environmental Factors Impacting Household and Personal Care Packaging
    Ink World

    Latest Breaking News From Ink World

    Heidelberg Well on Track after Three Quarters of FY2022/23
    Orion Carbons Announces New Distribution Partnerships
    DuPont Reports 4Q, Full Year 2022 Results
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    'Build Back the Wisconsin Paper Industry' event announced
    Magic Johnson to keynote Dscoop Edge St. Louis World Expo
    Norway's Digital Etikett grows with HP Indigo
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Edgewell’s Sales Increase
    Mitsui Chemicals, Asahi Kasei Combine Nonwovens Businesses
    Hospeco Offers TaskBrand Prep-Paint-Finish Wiping System
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    OssDsign Launches New Product for Additional Surgical Procedures
    OSSIO Introduces Non-Permanent Compression Staple
    Dennis Jones Joins Intelivation Technologies as Manufacturing VP
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Identiv Expands NFC and HF Solutions Portfolio
    HID Acquires GuardRFID to Expand Healthcare Offering
    DuPont Reports Fourth Quarter, Full Year 2022 Results

    Copyright © 2023 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