This webinar will describe the legal and regulatory basis for the de novo program and discuss the de novo device submission process. And provide information as to what constitutes a good quality de novo submission and will identify resources useful in preparing a de novo medical devices application.
Why Should You Attend:
The device approval process can be complex and time consuming and may not always result in obtaining FDA approval. Pursuing a Pre-Market approval or PMA approval for a new medical device can be especially costly and require substantial resource commitments. Knowing whether you can submit your device through the de novo process may result in cost savings not only in upfront resource burn but also in faster time-to-market for your medical device.
Areas Covered in this Webinar:
What is the definition of de novo? A brief history of the medical device regulations with respect to section 513 of the FD&C Act (device classification system)
Description of the de novo process (section 513(a)(1)) and the two pathways used to pursue FDA approval
Links to FDA guidance documents available and other useful references
Best practices and helpful hints to help facilitate the de novo process and submit a good quality application
Will be able to understand the similarities, interrelationships, and differences between 510(k), PMA and de novo medical device approvals
The appropriate path to take when seeking approval of a new medical device or new indication for use of a prior approved device
The different pathways to interact with the FDA when pursuing a de novo application
Knowledge of section 513(a)(1) of the Federal Food, Drug and Cosmetic Act (FD&C Act)
Who Will Benefit:
Medical Device Professionals
Regulatory Affairs Managers
Corporate Device Managers responsible for submitting medical device applications for new devices or for new indications for use
Small Business Owners who will be submitting a device for approval with the FDA
Recently retired after 29 years with the FDA, Regina was a senior compliance officer with the Office of Regulatory Affair (ORA) including over 7 years as a case review expert in the Office of Enforcement and Import Operations’ Division of Enforcement. Responsibilities included the review and analysis of complex, violative enforcement actions. Evaluated proposed advisory, administrative, and judicial actions for compliance with the Agency’s enforcement policy, regulatory objectives, and priorities, as well as determined the legal sufficiency of documented evidence.
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