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.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA Issues Final Guidance on Q-Submission Program

FDA Issues Final Guidance on Q-Submission Program

FDA_Logo_Blue_2016.gif
May 8, 2019

The FDA has released final guidance on the forms of meetings and feedback devicemakers can request for various submissions under the agency’s Q-Submission program.

The guidance outlines the options available to drug sponsors seeking input from the FDA for investigational device exemption applications, premarket approval applications, humanitarian device exemption applications, De Novo requests, 510(k) submissions, clinical laboratory improvement amendments (CLIA) waivers, dual 510(k) and CLIA waiver by application submissions (duals), accessory classification requests and certain INDs and BLAs.

The agency said the guidance reflects agreed-upon changes related to scheduling pre-submission meetings and clarifies other elements of the Q-Submission program.

“Early interaction with FDA on planned nonclinical and clinical studies and careful consideration of FDA’s feedback may improve the quality of subsequent submissions, shorten total review times, and facilitate the development process for new devices,” the agency said.

View today's stories

Medical Devices Regulatory Affairs

Upcoming Events

  • 10Mar

    FDA Drug GMP Facility Inspections During the Pandemic

  • 16Mar

    Pharmaceutical Naming Regulation: Understanding the Latest Developments

  • 18Mar

    Pharmaceutical Postmarket Surveillance: Latest Developments in the Era of COVID-19

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 30Mar

    Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges

  • 06Apr

    Medical Device Cybersecurity: Understand the Latest Developments

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Vaccine needle

    Turkish Researchers Downgrade Sinovac’s COVID-19 Vaccine Efficacy Rate

  • Luminex logo

    Luminex Receives EUA for Expanded Respiratory Pathogen Panel, Clearing It for COVID-19

  • Acquires -Acquired

    Amgen to Buy Five Prime Therapeutics for $1.9 Billion

  • abbott-logo.gif

    Abbott Secures EUA for COVID-19 Combination Test

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 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing