Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

FDA issues final guidance on third party reviews

March 11, 2020 By Nancy Crotti

FDAThe FDA today issued final guidance today for its 510(k) third party review program in an effort to channel agency staff time toward reviewing more complex devices.

The new guidance clarifies expectations for third party review organizations (3P510k review organizations) of how to meet the FDA’s standard for 510(k)-eligible product review and could eliminate the need for routine, duplicative re-reviews of certain information by FDA staff, according to the agency. The FDA also said it is updating the list of devices eligible for review under that program.

The third party review is designed to enable the FDA to focus its internal scientific review resources on higher-risk and complex devices, sending FDA-equivalent reviews of low- to moderate-risk and less complex devices to 3P510k review organizations. Greater use of the third party review program can reduce agency review times to 30 days or less, the FDA noted.

The program also provides manufacturers an efficient, consistent and predictable process to request review of 510(k) submissions by accredited, FDA recognized organizations, according to the agency.

Specifically, the final guidance:

  • Describes the factors the FDA uses to determine device type eligibility for review by third party review organizations.
  • Outlines the process for the recognition, re-recognition, suspension and withdrawal of recognition for 3P510k review organizations.
  • Seeks to ensure consistent quality of work among 3P510k review organizations.

A webinar for manufacturers 3P510k review organizations, and others interested in learning more about this final guidance has been scheduled for April 26, 2020. The final guidance can be found here.

Related Articles Read More >

A portrait of Zimmer Biomet CEO Bryan Hanson
Zimmer Biomet narrowly avoids shareholder rebuke on executive pay
A portrait of Britt Meelby Jensen, the new CEO of Ambu
Ambu replaces CEO with new leadership
AdvaMed
AdvaMed joins Biden’s Joint Supply Chain Resilience Working Group
A photo of former FDA official Bakul Patel
Google Health hires FDA’s chief digital health officer

DeviceTalks Weekly.

May 20, 2022
DeviceTalks Boston Post-Game – Editors’ Top Moments, Insulet’s Eric Benjamin on future of Omnipod 5
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

Enewsletter Subscriptions

Enewsletter Subscriptions

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
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • 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 E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. 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
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech