Скачать или смотреть 510(k) Success: Crafting Persuasive Substantial Equivalence Arguments Demo

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The 510(k) premarket notification pathway continues to evolve, with the FDA releasing a variety of guidance documents and recommendations in recent years. With so many new developments and proposals, regulatory professionals must stay educated and adapt in order to convincingly demonstrate substantial equivalence for a successful 510(k) review. As requirements continue to evolve, device manufacturers are revising and refining approaches for persuasively demonstrating substantial equivalence to stay current and compliant. This session will:
Provide updates on FDA 510(k) requirements, guidance, and initiatives
Pinpoint risk factors utilized by FDA when determining substantial equivalence
Address areas of ambiguity and strategize how to use these to your advantage
Identify tactics for successfully working with FDA


Speaker:
James M. Flaherty, Jr.
Associate General Counsel – FDA Regulatory
Fresenius Medical Care North America


Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:

Regulatory Affairs
Legal Counsel
Compliance Officers