The 21 Elements of a 510(k)

This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product requirements and documentation necessary to file a 510(k). The 510(k), in any of its three allowable formats, with up to 21 required elements. A brief discussion of how to address device changes and when to file a new 510(k). Consideration of the U.S. FDA's current K-97-1 Memo / guidance document on 510(k) Device Modifications: Deciding When to submit a 510(k) for a Change to an Existing Device, to provide tools to document such decisions.

Why Should You Attend:

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process for primarily Class II devices. The FDA holds companies responsible for filing new 510(k)s when new products are to be marketed in the U.S., or when existing products and/or their indications for use are changed. What are the steps and how are they documented? How is 510(k) vs alternatives, e.g., PMAs, determined? What should be included, and what should only be referenced. What concerns need to be addressed as a result of the FDA's August 2010 510(k) study and resulting January 2011 Report? The 3 types of 510(k)s and when used. The 21 mandatory elements to be addressed in a "Traditional" submission. Tougher requirements. Changed requirements. Software "in-" or "as-product"? How does Product Risk Management fit into the submission process? A typical sequence of events.

Learning Objectives:

• Mandated Areas for Annual Reviews
• FDA's "Strategic Priorities" for 2014 - 2018
• Tougher Regulatory Science - What "Better Science" Really Means
• Device, Pharmaceutical and Biological Issues
• General CGMP Issues - Strengthened Compliance
• Safety / Integrity of Global Supply Chain
• Heightened Supplier Issues
• Product Life Cycle - FDA clearance / approval only the beginning

Areas Covered in the Webinar:

• Current Requirements of the FDA for a 510(k) submission
• Expected Sources of Information for Evaluation and Inclusion
• The 3 Types of 510(k) Submissions, and Their Uses
• Step-by-step analysis of the 21 Elements
• Changes to a Device after FDA Clearance
• Expected Submission Sequence of Events

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) analysis and preparation / submission activities, based on the FDA's current guidance documents. It will briefly discuss how companies can best address changes to devices already cleared - whether or not a new 510(k) filing is warranted. This applies to companies in the Medical Device and combination products fields. The employees who will benefit include:

• Senior management
• Regulatory Affairs
• Quality Assurance
• Production
• R&D and Engineering
• Marketing and Sales

Instructor Profile:

John E. Lincoln, consultant, has successfully designed, written over 50 ISO 14971-compliant Risk Management Files / Reports, including FMECA and FTA analysis, many in response to FDA 483 observation, which have subsequently passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development / design control projects; with over 24 years of experience, primarily in the medical device industry – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP.