{domain:"www.qualitydigest.com",server:"169.47.211.87"} Skip to main content

User account menu
Main navigation
  • Topics
    • Customer Care
    • FDA Compliance
    • Healthcare
    • Innovation
    • Lean
    • Management
    • Metrology
    • Operations
    • Risk Management
    • Six Sigma
    • Standards
    • Statistics
    • Supply Chain
    • Sustainability
    • Training
  • Videos/Webinars
    • All videos
    • Product Demos
    • Webinars
  • Advertise
    • Advertise
    • Submit B2B Press Release
    • Write for us
  • Metrology Hub
  • Training
  • Subscribe
  • Log in
Mobile Menu
  • Home
  • Topics
    • 3D Metrology-CMSC
    • Customer Care
    • FDA Compliance
    • Healthcare
    • Innovation
    • Lean
    • Management
    • Metrology
    • Operations
    • Risk Management
    • Six Sigma
    • Standards
    • Statistics
    • Supply Chain
    • Sustainability
    • Training
  • Login / Subscribe
  • More...
    • All Features
    • All News
    • All Videos
    • Contact
    • Training

Study: FDA 510(k) Approval Process Now Averages Six Months

For some device manufacturers, third-party reviewers could reduce that to 68 days

Michael Causey
Wed, 07/15/2015 - 12:27
  • Comment
  • RSS

Social Sharing block

  • Print
Body

If you’ve got six months—and nerves of steel—here’s some good news: You have a 61-percent chance of getting your medical device approved by the Food and Drug Administration (FDA). That’s one nugget of interesting data to be found in a recent Emergo Group report that analyzed some 15,000 device clearances between January 2010 and December 2014.

ADVERTISEMENT

We’ve blogged about this quite a lot during the past four years, and it looks to be another case of the more things change, the more they stay the same. Back in June 2011, we reported on an Emergo study, which found that in 2006 it took about 96 days to get clearance. By 2010 that number had leapt to 132. Today, Emergo reports that “it now averages about six months.” Blame for this trend is slung around between industry and regulators. Each time the FDA says it’s made a big step forward, industry tends to toss these stats back in the agency’s face.

 …

Want to continue?
Log in or create a FREE account.
Enter your username or email address
Enter the password that accompanies your username.
By logging in you agree to receive communication from Quality Digest. Privacy Policy.
Create a FREE account
Forgot My Password

Add new comment

Image CAPTCHA
Enter the characters shown in the image.
Please login to comment.
      

© 2025 Quality Digest. Copyright on content held by Quality Digest or by individual authors. Contact Quality Digest for reprint information.
“Quality Digest" is a trademark owned by Quality Circle Institute Inc.

footer
  • Home
  • Print QD: 1995-2008
  • Print QD: 2008-2009
  • Videos
  • Privacy Policy
  • Write for us
footer second menu
  • Subscribe to Quality Digest
  • About Us
  • Contact Us