510(k) Applications made Simple

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

Description
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.