510(k) Applications made Simple

Instructor: E.J Smith
Product ID: 701082
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Dec-2008

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

This 510(k) Training covers the content requirements of a traditional 510(k) application and covers in detail the recommended 20 sections.


This 510(k) Training deals only with those medical devices that require a 510(k) application. All Manufacturers introducing Class II medical devices to the US market must submit a FDA 510(k). It is also required for manufacturers that are changing the intended use of the medical device, or changing the technology of a cleared device such a way that it may significantly affect its safety or effectiveness.

Most medical devices fall into two categories; Class I or Class II. Most Class I devices are exempt from Premarket Notification 510(k) while most Class II devices require a Premarket Notification 510(k) application. This course deals only with those medical devices that require a 510(k) application. This presentation covers the content requirements of a traditional 510(k) application and covers in detail the recommended 20 sections. This presentation also covers early collaboration with the FDA which will help avoid delays in your 510(k) review.

Areas Covered in the seminar:

  • Early collaboration with FDA.
  • Formatting.
  • 510(k) Summary.
  • Executive Summary.
  • Financial Disclosure.
  • Compliance to Standards.
  • Intended Use Statement.
  • Proper device description.
  • Substantial equivalent discussion.
  • Label requirements.
  • Biocompatibility requirements.
  • Electrical Safety requirements.
  • Software presentation (Level of Concern).
  • Bench Tests.
  • Clinical information.

Who will benefit:

  • Executive management
  • Regulatory management
  • R&D personnel
  • Investors in medical device companies
  • Sales and Marketing managers
  • Small Business Qualification
  • User Fee

Instructor Profile:

E.J. Smith, is a co-founder of Smith Associates, a FDA regulatory consulting firm that specializes in the preparation of 510(k), PMA and IDE submissions, device and cosmetic labeling, quality system audits and clinical trials. E.J. is the author of Hospital Consumables and Smith’s Reference and Illustrated Guide to Surgical Instruments and has 43 years of experience in medical marketing, executive positions and FDA regulatory affairs.

Follow us :
Latin America: Regulatory Compliance Requirements for Life Science Products
Managing Your Complaints and Obstacles in Post-Market Requirements

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-717-2436 (Toll Free).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed