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 to Seek Public Comment on IOM Recommendations

July 29, 2011 By Bio-Medicine.Org

SILVER SPRING, Md., July 29, 2011 /PRNewswire-USNewswire/ — The
FDA today announced that it will open a public docket to begin
receiving public comments on the Institute of Medicine’s (IOM)
report on the 510(k) program, the most common pathway to market for
lower-risk medical devices.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

The FDA commissioned the report in September 2009. While none of
the IOM’s recommendations are binding, the FDA is planning a public
meeting in the coming weeks to discuss recommendations made in the
report, titled “Medical Devices and the Public’s Health: The FDA
510(k) Clearance Process at 35 Years.”  

“We appreciate the IOM’s report on the 510(k) program, and agree
that the public should continue to feel confident in the medical
devices on the market today,” said Jeffrey Shuren, M.D., director
of the FDA’s Center for Devices and Radiological Health.

“Medical devices in the U.S. have a strong track record of
safety and effectiveness. The 510(k) program has helped support a
robust medical device industry in the U.S. and has helped bring
lower-risk devices to market for the patients who need them.”

“FDA believes that the 510(k) process should not be eliminated
but we are open to additional proposals and approaches for
continued improvement of our device review programs,” Shuren
said.

In order for a manufacturer to begin marketing a device subject
to 510(k) review, FDA must “clear” a premarket notification
(510(k)) demonstrating that the new or modified product is
substantially equivalent to another legally marketed “predicate”
device.  

Some of the IOM’s recommendations, such as the recommendation to
design a new regulatory framework for Class II (moderate risk)
devices, may require congressional actions. However, the FDA plans
to continue its review of the report and to solicit input from
stakehold

‘/>”/>

SOURCE

Related Articles Read More >

Dexcom One
How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age
A Medtronic HVAD pump opened up to show the inner workings
Medtronic investigates HVAD pump welds after patient deaths
Galien Foundation 2022 nominees
18 of the world’s most innovative medical technologies

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