510(k) Preparation, Submission and Clearance: Dos and Don’ts

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Description:

FDA recently issued final 510(k) guidance, providing FDA’s policy on the 510(k) program.

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

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

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 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 to be Covered:

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: How to Prevent Them: 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 will Benefit:

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

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.

This product is currently out of stock and unavailable.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance