Construct a 'Real' 510(k) Submission: From Start to Finish

This 510(k) Submission Webinar will provide a unique opportunity for the participants to create a Traditional 510(k) application and ensure that proper formatting and content are used prior to submitting to FDA.

Why should you Attend:
A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process. This Webinar will provide a unique opportunity for the participants to create a Traditional 510(k) application and ensure that proper formatting and content are used prior to submitting to FDA. Ample time will be allocated for Q&A and participation is strongly encouraged.

Participants will create a new 510(k) application from beginning to end. The 510(k) submitter should prepare and submit a complete application in order to obtain marketing clearance. To facilitate FDA review of the data, analysis, and conclusions in the application, the manufacturer should check for theological presentation of the data; scientific soundness of the test and data analysis; relevance of the test program to the device and the intended use; and completeness of the summary report of the tests or studies. A description of the tests and the results obtained are essential. Reasonable and sufficient details of all test procedures and results should be submitted to FDA. Learn about additional Formatting Tips.

Understand the FDA decision-making process. Obtain and use the right guidance. This Webinar will introduce the participants and provide a real-life example on how to properly construct your application and ensure that all substantive details are provided.

Areas Covered in the seminar:

• Know what goes into the Traditional submission.
• Understand Substantial Equivalence and how it is applied.
• Understand the value and significance of the Table of Contents and Cover Sheet.
• Participants will create and learn how to submit the completed application.
• Special tips and why writing style and skills are important.
• Justify the use of the "predicate" device and why a comparison is important for your Traditional 510(k).
• Understand and apply recommended formatting tips and guidelines to make this work and a success.
• Create a Traditional 510(k) from the initial cover sheet to the final package for submission to FDA.

Who will benefit:

All end-users from appropriate departments who desire or require a better understanding or a "refresh" overview of how to create, manage and submit the 510(k) to FDA for review and approval. Webinar will emphasize and focus on creating a Traditional 510(k) application using real-life device example.

This webinar will provide valuable assistance and guidance to device companies that need to prepare and submit a Traditional 510(k) application. The employees who will benefit include:

• QA and Compliance
• Regulatory Affairs Management and RA Specialists
• Marketing
• Consultants
• Engineering/Operations

Instructor Profile:
David R. Dills, Indpendent Regulatory & Compliance Consultant, departed PAREXEL Consulting in July 2008 due to service line organizational change. Prior to joining the consultancy Mr. Dills has provided independent consultative services in various capacities from pre-marketing to post-marketing within the technical, quality, regulatory affairs and compliance arena to pharmaceutical, Class I/II/III medical devices, in vitro diagnostics and biologics/biotech companies with an emphasis on establishing sustainable compliance systems. Through his work, Mr. Dills has been affiliated within the life sciences industry for more than nineteen years with increasing responsibilities in QA/Quality Systems, Regulatory Affairs/Compliance, and Corporate/Operations Management and previously employed on behalf of globally recognized device manufacturers and service providers.

Key areas of focus include product development and commercialization strategies, regulatory classifications, applications and submissions, regulatory and clinical consulting, rapid regulatory crisis response, involved in consent decree/CIA activities, improve and remediate quality management systems and documentation, inspection readiness preparedness for manufacturers and serves in an Expert Witness capacity for a third party. Mr. Dills has prepared and executed effective paths to obtaining approvals, worked effectively across functions for overall corporate compliance, and aligned GxP compliance in a fashion that supports a company’s business strategies and goals.

Key areas of focus also include product development and commercialization strategies, regulatory classifications, applications and submissions, rapid regulatory crisis response, and inspection readiness preparedness for manufacturers. He adds business value to device companies by providing strategic and tactical solutions that facilitate the achievement of regulatory milestones. The focus is on planning, implementation, and training for all phases of the regulatory review and approval process, and on minimizing delays due to regulatory noncompliance.

He has a proven track record and an accomplished regulatory professional working not only with several Notified Bodies and FDA/CDRH/ODE representatives but also international regulatory bodies in Japan, EU, Australia, Canada and other locales. He has worked on and currently working on several J-STED files and Ninsho Certification, IDEs, PMAs and 510(k) submissions and applications, as well as serving on teams related to clinical trials development and deploying sustainable and proven strategies.

Mr. Dills areas of interest and expertise include executing process validation, supplier qualification, training, internal/due diligence audits, policy/procedure development, PM, risk management/assessment, ISO 9001/13485/14971, MDD 93/42/EEC, CE Marking, remediation, GxPs, SW Validation/IT Network, MDR/AE/product complaints, design/change control, CAPA, PMA, IDE, 510(k), NDA and e-CTD/CMCs submissions, interfacing with international regulatory bodies, QSIT and PAI Inspections, product registration, J-STED/Ninsho activities, and training.

Mr. Dills currently serves on the Faculty Advisory Board for the Pharmaceutical Training Institute and Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology. He serves on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore’s Who’s Who of Professionals. Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter.

Mr. Dills’ academic degrees include Environmental Science and Biology. He currently serves as Advisor for the ASQ’s Section 1506 and as a former Chair and Co-Chair and is an active member of the Biomedical Division, RAPS, PDA, ISPE, and other industry working groups.