US FDA 510(k): Due Diligence, Preparation, Submission and Clearance

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
60 Minutes
Product Description

Get Familiar With Due Diligence Activity and Current US FDA 510(K) Processes – Preparation, Submission and Clearance

Although a number of factors have lead to the 510(k) clearances, industry veterans feel that it is important for medical device manufacturers to understand the recent changes (hurdles and new requirements) and be able to prepare a 510(k) in a sufficiently adequate way to expedite the review process and successful clearance without delays.

In this power-packed conference, join our expert, Dr. David Lim, Ph.D., RAC, ASQ-CQA, as he discusses what and how to do with your 510(k) preparation and submission. He will also share what he has learned from his own experience based on his analysis of recently cleared 510(k)s.

You will learn how to demonstrate due diligence activity when contemplating a 510(k) submission, how to prepare a 510(k), submit and clear it in accordance with FDA’s eCopy and RTA policy so that your time, energy and financial resources can be effectively used to accelerate your 510(k) clearance, potentially saving millions.

Here's a look at what David will cover:

  • Statute(s) and regulations
  • Regulatory requirements for 510(k)s
  • Device classification and predicates
  • When 510(k)s are required
  • Demonstrating substantial equivalence
  • Recent 510(k) changes and requirements including e-Copy and RTA policy
  • Product codes
  • Regulatory requirements for products
  • How to address and present performance data and/or clinical data in a succinct manner
  • How to respond to FDA’s request of additional information
  • How to resolve different opinions between the submitter and FDA reviewer(s)

Who should attend?

RA, R&D, QA/QC/QS, CROs, Consultants, Contractors/subcontractors, Senior management, Anyone interested in 510(k) matters

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor ( As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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