US FDA 510(k) – Latest Guidance, Due Diligence, Preparation, Submission and Clearance

The United States Food and Drug Administration (FDA) recently issued final 510(k) guidance, providing FDA’s policy on the 510(k) program.

This seminar will provide a great opportunity to get familiar with how to best prepare for a 510(k) for submission to the FDA and clearance: in particular, recent trends including best practices (Dos and Don’ts).

Based on speaker’s recent experience, he will discuss best practices for adequately putting your 510(k) together compliant with the FDA’s policy and requirements.

This presentation will greatly help you streamline your 510(k) preparation and submission process at your firm for maximum benefits in a least burdensome, effective manner, in accordance with lastest guidance.

In this presentation, the speaker will share his PASS-IT solutions based on what he has learned from his own experience including his recent analysis of various different types of 510(k)s that have been recently cleared.

This presentation is a must for regulatory professionals working in medical device industry including those who are interested in the topic.

Areas Covered in the Session :

• Laws And Regulations
• Definitions
• Device Classification
• Predicates
• Recent FDA Final 510(k) Guidance
• When a 510(k) Is Required
• 510(k) Requirements
• Substantial Equivalence: Factors to Consider and Special Considerations
• Addressing e-Copy And RTA Policy Requirements
• Common Mistakes for eCopy and RTA Policy Requirements
• Common 510(k) Pitfalls to Avoid: Dos and Don’ts
• What to Ensure While Preparing for a 510(k) Application
• Responding to FDA’s Request of Additional Information.
• Resolving Different Opinions and Interpretations
• Best Practices for 510(k) Contents and Format
• PASS-IT Recommendations: Dos and Don’ts

Who Should Attend:

• Medical Device Quality and Compliance Departments
• Pharmaceutical Compliance Departments
• Quality Departments
• Regulatory Affairs Departments
• CEOs
• VPs
• Attorneys
• Clinical Affairs Professionals
• R&D Departments
• Consultants
• Contractors/Subcontractors
• Anyone Interested in the 510(k) Matters

Course Director: DR. DAVID LIM ‎

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.