Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe

FDA launches pilot to shorten some 510(k) approval times

October 2, 2018 By Nancy Crotti

The FDA has launched an interactive pilot program to streamline the 510(k) application for certain moderate-risk devices ranging from percutaneous catheters to lacrimal stents and intubation sets.

The Quality in 510(k) “Quik” Review Program uses the agency’s eSubmitter software to format each submission and accepts 39 product codes for device types that it considers to be well-understood by the FDA. The agency’s goal is to make a final decision within 60 days of receipt of a 510(k) application for an eligible device.

The FDA said the pilot will help it evaluate the Quik Review program and determine whether the eSubmitter software will produce well-organized submissions that can be reviewed more efficiently to help promote timely access to safe, effective, and high-quality medical devices.

The eSubmitter template asks for the same information typically requested in a traditional 510(k). After it is constructed, the eSubmitter application will format the submission into a ZIP file that filers should copy to a CD, DVD, or USB drive. Eligible devices must be regulated by the FDA’s Center for Devices and Radiological Health (CDRH). Combination products such as drug-device or biologic-device combinations are not included. Instructions for downloading and installing the eSubmitter application are available at the eSubmitter Download and Installation website.

If the submission is eligible for the Quik Review program pilot, the agency will not conduct a refuse-to-accept review or plan to put the submission on hold to request additional information. Instead, submitters are expected to respond quickly to FDA requests for additional information.

If the 510(k) is found to be ineligible for the Quik Review pilot, the FDA will email the official contact of the 510(k) to inform them of this decision and the reason why a review cannot be completed within 60 days. Then the 510(k) will be reviewed according to standard procedures using the traditional 90-day timeframe.

Related Articles Read More >

A photo of an FDA employee in the FDA Life Sciences Laboratory I in Building 64, which houses the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health.
Device developers must take action as experts leave FDA
This is the logo of MedTech Innovator.
MedTech Innovator announces 65 startups for its 2025 cohort
This is the logo of the U.S. Food and Drug Administration or FDA.
FDA rolls out ‘Elsa,’ a generative AI tool to boost efficiency across the agency
Proactive IP strategy to navigate your medtech startup through uncertain times
“mdo
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest medical device business news, application and technology trends.

DeviceTalks Weekly

See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to our E-Newsletter
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe