Best Practices to Obtain FDA Feedback Prior to Premarket Notification 510(k) and De Novo

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Conference Date
Wed, Jun 06, 2018
60 minutes
Product Description

What Does FDA Think of Your Product? Here’s How to Find Out

Your medical device is headed to market, but before it can go up for sale you need approval by the Food and Drug Administration (FDA). FDA can give powerful feedback on your device, but the process is by no means clear or straightforward. Now is when a little insider information would help.

Join regulatory compliance expert Dr. David Lim in this instructive session as he reveals how the FDA handles product feedback and how you can harness it to your advantage. You’ve got questions, and the FDA can help answer them.

After attending this audio event, you will know applicable statutes and regulations, industry definitions, FDA policy and process, how to request a meeting, what questions to ask, how to address regulatory questions to the FDA, regulatory requirements for 510(k) and de novo— and common pitfalls and how to prevent them.

Session Highlights

Here is a taste of what you will uncover:

  • Applicable statutes and regulations
  • Definitions
  • FDA policy and process
  • How to request a meeting
  • What questions to ask the FDA
  • How to address regulatory questions to FDA
  • Regulatory requirements for 510(k) and de novo
  • Common pitfalls and how to prevent them
  • Best practices for interacting with FDA reviewers
  • PASS-IT recommendations

Who Should Attend

  • CEOs
  • VPs
  • Compliance officers
  • Attorneys
  • Regulatory affairs
  • Clinical affairs
  • Quality assurance
  • R&D
  • Consultants
  • Contractors and subcontractors

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

Order Below or Call 1-844-384-4744 Today

You can also order through:




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
More Events By The Speaker

Why AudioEducator?
  • Save money on travel.
  • Meet your specific training needs.
  • Keep learning after the event.
  • Save time training your whole staff.
Join Our Mailing List
Our Accreditation Partners
Facebook Twitter Linkedin Youtube RSS Feeds Google Plus
Audio Educator


Dear Valued Customers


We regret to announce that ProEdTech LLC and all its affiliate brands will cease operations on April 1, 2019.


We are no longer able to fulfill online orders. We will fullfill all DVD and book orders already placed.


Customers of canceled webinars and subscription products may request a refund at (800) 223-8720 or You must do so by April 1, 2019.


Thank you for your business and loyalty over the years. We sincerely apologize for any inconvenience caused.


Best regards,

The ProEdTech Team