Get FDA Regulatory Question for Premarket Notification & De Novo

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

Event Information
Product Format
Prerecorded Event
Presenter(s)
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Conference Date
Wed, Jun 06, 2018
Length
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 1-866-458-2965 Today

You can also order through:
Phone

1-866-458-2965

Fax

1-919-287-2643

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 (www.RegulatoryDoctor.us). 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

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