US FDA 510(k): Best Practices for 510(k) Preparation and Submission
Wednesday, January 22, 2014 from 10:00 AM to 11:00 AM (PST)
This webinar will discuss best practices for premarket notification [510(k)] preparation and submission compliant with FDA's eCopy and Refuse to Accept (RTA) Policy requirements.
Why Should You Attend:
Although it is believed there are various factors contributing to timing of 510(k) clearances, it is imperative more than ever from our industry perspectives that the medical device manufacturers understand 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, saving an enormous amount of time, energy, and resources.
In this webinar, speaker will discuss how to put together a compelling 510(k) package. In particular, the speaker will share what he has observed and learned from his own experience and also based on his analysis of 510(k)s recently cleared.
This 60-minute webinar will provide great opportunity to implement your good practices for a 510(k) preparation and submission while meeting eCopy and RTA policy requirements necessary for obtaining 510(k) clearances.
Areas Covered in the webinar:
- Statute(s) and regulations governing 510(k)s
- Definitions and medical device classification including IVD devices
- Intended use, indications, and predicates
- eCopy program
- Refuse to accept (RTA) policy
- Standards - benefits
- Who/when is required to submit a 510(k)
- Regulatory requirements: performance testing and/or clinical data
- 510(k) content and format
- How to increase 510(k) submission quality for a product.
- Responding to FDA’s request of additional information.
- Resolving different opinions between the submitter and FDA reviewer(s)
- Good practices: Dos and Don’ts including de novo process
Who Will Benefit:
- Regulatory affairs (associates, specialists, managers, directors or VPs)
- Quality professionals (associates, specialists, managers, directors or VPs)
- R&D (engineers, scientists, managers, directors or VPs)
- Complaint and risk management personnel
- Clinical affairs (associates, specialists, managers, directors or VPs)
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use, compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.