Medical Devices Group

  • Community
  • Webinars
  • Jobs
  • Events
  • Contact
  • Go Premium
« Back to Previous Page
Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
August 2014
FDA Said No
2 min reading time

19 months ago we featured group member Mark DuVal’s Citizen Petition and Petition for Stay of Action with the FDA.

Read that discussion: http://bit.ly/FDA_petition

The petition challenged FDA’s practices and interpretations for reviewing 510(k)s and asked the Commissioner to stay the implementation of “Draft Guidance: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” It sought reversion to older guidance.

FDA wrote back and said no. Instead, FDA issued new 510(k) guidance as planned. See http://bit.ly/New-510k-Guidance

In its refusal letter at http://bit.ly/FDA-said-no FDA wrote “your petition for stay of action fails to demonstrate it meets the conditions for FDA to grant the petition.”

Mark writes to his clients:

FDA does not realize and will not accept the serious impact its administration of the 510(k) program has had on innovation and investment in innovation… Its conservative, risk averse interpretations have brought little to no additional safety to devices being cleared or approved. In fact, we believe FDA’s current approach certainly has stifled innovation and failed to bring the benefit of new therapies to the market.

Read the rest at http://bit.ly/Marks-reply and see some benefit-of-the-doubt conclusions he makes.

Do you share Mark’s viewpoint? Will the new 510(k) stifle your innovations?

++++++++++

Discussions This Week:

What to do when in trouble finding (good) representation?
http://bit.ly/appointing-a-representative

Is Misogyny in Medtech an Issue?
http://bit.ly/women-in-medtech

How do you estimate the expected life of a device?
http://bit.ly/expected-life

I have my Class II prototype. What do I do next?
http://bit.ly/whats-next-II

510k each time I make a change?
http://bit.ly/510-each-time

++++++++++

IN CASE YOU MISSED

I’ve been putting the 10x Medical Device Conference presentations online on the http://MedicalDevicesGroup.net blog.

Now available:

• Daniel Kraft’s keynote on Reimagining Health, Medical Devices, and BioMedicine

• Marty Kohn on Big Data Analytics and the Transformation of Healthcare

• Ken Ritterspach on How Medical Device Company SurModics Uses Analytics

• Dave Sheppard on Global Medical Device Channel Management

• Seth Goldenberg on Medical Device Development to International Markets

More to come: http://MedicalDevicesGroup.net

++++++++++

Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. Video: 8 minutes about Prostrate Cancer Screening http://bit.ly/prostate-cancer-testing

Marked as spam
Posted by Joe Hage
Asked on August 27, 2014 7:00 am
32 views
  • Follow
  • Unfollow
  • Report spam

Meet your next client here. Join our medical devices group community.

« Back to Previous Page

Please log in to post questions.

  • Go to WP login page

Stay connected with us.

By signing up you are agreeing to our Privacy Policy.

Categories

  • Capital/Investment
    • Business Model
    • Funding
  • Careers
  • Design/Devel
    • Design
    • Development
    • Human Factors
    • Labeling
    • Material Selection
    • R&D
    • Trials and Post-Market
  • Featured
  • Industry
    • Announcements
    • Device Tax
    • Hospital and Health Care
    • Innovation
    • Medtech
  • LinkedIn, etc.
  • Markets
    • Africa
    • Americas
    • Asia
    • Australia
    • Europe
  • Regulating
    • CE Marking
    • EU
    • FDA
    • FDA/EU etc.
    • Notified Bodies
    • Quality
    • Regulatory
  • Selling
    • Distribution
    • Intellectual Property
    • Marketing/Sales
    • Reimbursement
  • Worth bookmarking!
Feature your job here.
logo

Companion to LinkedIn's 350,000 member community

  • Contact
  • Medical Device Marketing
  • In Memoriam
  • Medical Device Conference

The Medical Devices Group   |   Copyright © Terms, Conditions & Privacy

Medical Devices Group
Powered by  GDPR Cookie Compliance
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.

Strictly Necessary Cookies

Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.

If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.