{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

FDA Pilot Program Encourages Quarterly Malfunction Summary Filings

Michael Causey
Tue, 09/01/2015 - 16:37
  • Comment
  • RSS

Social Sharing block

  • Print
Body

FDA will be taking applications starting Sept 1, 2015, looking for makers of class I and suitable class II medical devices to participate in a pilot program to file malfunction reports in summary form quarterly. Get on the stick, though, if you are interested: there are only nine slots.

ADVERTISEMENT

Under FDA’s Medical Device Reporting on Malfunctions, the agency hopes to streamline some reporting procedures. It wants any reports to include a “narrative text” with sufficient detail for a reviewer to understand what happened. The agency also expects to hear about subsequent investigations and corrective actions as necessary to address the situation(s).

There’s a carrot, too: manufacturers accepted into the pilot will be granted an exemption or variance from, or alternative to, the usual reporting requirements under 803.5 and 803.52 for covered devices. Accepted candidates can withdraw from the pilot program at any time. FDA can drop participants, too.

 …

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