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 » FDA UNVEILS 'MEDICAL DEVICE INNOVATION INITIATIVE'

FDA UNVEILS 'MEDICAL DEVICE INNOVATION INITIATIVE'

May 30, 2006

In recognition of the sometimes dizzying pace at which innovation is taking place in the medical device industry, the FDA announced last week that it was launching an initiative designed to approve devices more quickly by modernizing the development process.

New technologies present challenges for both the agency and devicemakers "because the current paradigms for assessing the safety and effectiveness of new products may not be optimal" for an efficient review process, the FDA said in announcing its "Medical Device Innovation Initiative."

Innovations in devices are beginning to integrate engineering and biological approaches, the agency said. These technological advances include "complex products" such as diagnostic products using nanotechnology and combination products such as drug-delivery devices. This innovation runs the gamut from "giant leaps" of as short as 18 months to "incremental" changes that can take years.

The agency wants to better predict which new products are likely to be safe and effective earlier in the regulatory process. One of its primary goals is to ensure that clinical trials, product reviews and approvals, and manufacturing processes are conducted as efficiently and effectively as possible.

The Center for Devices and Radiological Health (CDRH) is promoting early interaction between the FDA and industry to optimize review times and foster innovation, the FDA says. ()a href="http://www.fdanews.com/ddl/33_22/" target=_blank>

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