LoginRegister
Life Science Training Institute
  • Courses
    • All Courses
    • Upcoming Live Courses
    • By Category
      • Clinical Trials
      • Manufacturing
      • Med Device
      • Regulatory
      • R&D
      • Leadership & Training
    • Meet the Instructors
  • Blog & Resources
  • About Us
    • About LSTI
    • Enterprise Solutions
      • CRA Academy
      • GxP Refresher Courses
    • FAQs
    • Contact Us
    • Email Communications
  • View Cart
  • Join Our Mailing List
  • Courses
    • All Courses
    • Upcoming Live Courses
    • By Category
      • Clinical Trials
      • Manufacturing
      • Med Device
      • Regulatory
      • R&D
      • Leadership & Training
    • Meet the Instructors
  • Blog & Resources
  • About Us
    • About LSTI
    • Enterprise Solutions
      • CRA Academy
      • GxP Refresher Courses
    • FAQs
    • Contact Us
    • Email Communications
  • View Cart
  • Join Our Mailing List
Life Science Training Institute > Resources > 501(k)
4 reasons your 510(k) submission will be rejected (and how to avoid them)

While a high percentage of FDA 510(k) submissions are rejected the first time (69%!), yours doesn’t have to be one of them.

Posted in:FDA,
Tags:501(k),FDA,

STAY TUNED WITH US

This form needs Javascript to display, which your browser doesn't support. Sign up here instead

Resources by topic

Upcoming Live Courses

  • The Value of The Medical Affairs Organization – A Comprehensive Overview
  • Clinical Study Requirements – Understanding Differences Between the US and EU
  • Authoring and Implementing Standard Operating Procedures (SOPs): Best Practices for Success
  • Building a Best in Class Medical Affairs Organization: Strategies for Success
  • CAPA and Root Cause Analysis: Essentials Post ICH GCP E6 (R2) Addendum
  • Cleaning Validation – Lessons Learned in the Trenches
  • Right to Try Legislation: Impact on Industry, Health Authorities, and Patients
  • FDA Regulations for Analytical Instrument Qualification and Validation: Comprehensive Best Practices
  • Cell Therapy: Process Design Considerations To Support Commercialization
  • Aging Biotech and Aseptic Facilities - Renovation for Survival

About

The Life Science Training Institute helps pharma, biotech, and medical device companies build knowledgeable, compliant workforces by providing training from drug discovery through commercialization.

We are dedicated to advancing careers of those working to develop new therapies and to protect patient safety.

EMAIL COMMUNICATIONS

Get LSTI Email Communications straight to your inbox.

Sign Up Here

Contact

  • 101 Gibraltar Road, Suite 100. Horsham, PA 19044
  • 215-675-1800 (option 3)
  • info@lifesciencetraininginstitute.com

View Courses

  • Clinical Trials
  • Manufacturing
  • Med Device
  • Quality
  • Regulatory & Compliance
  • Research & Development
  • Leadership & Training
  • IT & Data
  • Upcoming Live Courses
  • On Demand Courses
  • Introductory Courses
  • Special Packages

Search Courses

Footer logo
Copyright © 1996-2017 VertMarkets, Inc. All Rights Reserved.
  • home
  • About LSTI
  • courses
  • Enterprise
  • Privacy
  • Terms
Search