We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » SURVEY: MDUFMA HAS NOT IMPROVED FDA DEVICE REVIEW TIMES

SURVEY: MDUFMA HAS NOT IMPROVED FDA DEVICE REVIEW TIMES

May 2, 2006

Nearly 70 percent of device manufacturers say the FDA's Medical Device User Fee and Modernization Act of 2002 (MDUFMA) has not improved the predictability or timeliness of device reviews, according to a survey conducted by the Lewin Group for the FDA.

The Lewin Group surveyed 30 device manufacturers about MDUFMA, which authorizes the agency to collect fees from devicemakers to supplement device review appropriations. Those funds are meant to be used to hire additional reviewers to streamline the review process.

Most respondents expressed support for MDUFMA's purpose and goals and commended the approach of balancing faster review time and safety. But they were also skeptical about whether the program is achieving its purpose or has "yielded a return on the investment of industry user fees and other resources devoted to the program."

Some respondents said MDUFMA has not improved predictability and that review times have remained "about the same" compared to pre-MDUFMA experiences. Being able to anticipate how long it takes to get new devices to market is critical to manufacturers, particularly for smaller device firms with limited resources, they said. Monitoring and tracking the FDA's cumulative review time is critical moving forward, and the agency should consider expedited review for novel and "breakthrough" technologies, they added.

(http://www.fdanews.com/ddl/33_18/)

KEYWORDS FDAnews Device Daily Bulletin

Upcoming Events

  • 08Sep

    Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections

  • 15Sep

    Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis

  • 20Sep

    Building a World-Class Pharmaceutical Advertising and Promotion Review Program

  • 21Sep

    The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval

  • 22Sep

    FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers

  • 11Oct

    1st Annual Quality Management vSummit

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • AngioDynamics Gets Expanded Clearance for Auryon Atherectomy System

  • Aura Biosciences Receives Fast Track Designation for Bladder Cancer Candidate

  • FDA Issues Update on Becton Dickinson’s Recall

  • FDA Grants Accelerated Approval to Enhertu for HER2-Mutant NSCLC

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing