This seminar presentation will provide great opportunities to get familiar with the “Best Practices” on how to obtain FDA’s constructive feedback on regulatory questions prior to preparing for and submitting a 510(k) and de novo request. In particular, the speaker will discuss his recommended best practices including dos and don’ts.
Based on speaker’s compiled experience over the years, he will discuss his practical, actionable recommendations to help industry understand how to best use FDA process to obtain constructive feedback on various questions during device design, development, premarket notification and de novo request. The speaker will also discuss recent guidelines on 510(k) and de novo request in compliance with the FDA’s recent policy.
This presentation will greatly help you how to get constructive comments from FDA reviewers prior to 510(k) submission and de novo request.
In this presentation, the speaker will share his PASS-IT solutions based on what he has learned from his own experience while working at FDA and/or interacting with FDA reviewers, FDA management, and 510(k) staff.
This presentation is a must for regulatory professionals working in medical device, IVD and healthcare industry.
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). Dr. Lim is a leading industry speaker and has presented and addressed FDA regulatory and compliance matters in various forums and meetings.
Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance matters. Dr. Lim has also advised many firms including, but not limited to risk management firms, venture capital firms, asset management firms, and fund managers to make right investment decisions in view of FDA regulatory and compliance matters.
01:00 PM EST 12:00 PM CST 11:00 AM MST 10:00 AM PST