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.
Here is a taste of what you will uncover:
Who Should Attend
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
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.