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510(k): Format, Contents and Case Studies Description: This webinar is intended to demonstrate how to prepare a 510(k) in a manner to facilitate the review and for successful clearance. The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) describes the premarket notification requirements. The premarket notification [510(k)] is the most common pathway to market for medical devices. The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is subs tantially equivalent (as least as safe and effective) to a legally marketed device (predicate device) as described in 21 CFR 807.92(a)(3). In other words, 510(k)s must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA). Over time, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process. To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device manufacturers understand the recent changes and be able to prepare for a 510(k) in a way to expedite the review process and successful clearance. At the end of the webinar, you will feel empowered in that you would take or choose to take different approaches to prepare for and submit your next 510(k). Objectives of the Presentation: o Statute(s) and regulations governing 510(k) o Definitions and medical device classification including in vitro diagnos tic medical devices o

Who should submit 510(k)s and when required to submit 510(k)s

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How to identify a suitable predicate device(s), if any

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How to demonstrate substantial equivalence

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Recent changes in the 510(k) program

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Decision points during 510(k) review

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Differences in contents of 510(k)s based on products

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How to identify regulatory requirements relevant and applicable to the product(s)

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How to address the relevant and applicable regulatory requirements

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How to present your performance data and clinical data in a succinct, comprehensive manner

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How to increase 510(k) submission quality for a product

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How to respond to FDA’s request of additional information

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How to resolve different opinions between the submitter and FDA reviewer(s).

Who can Benefit: o Regulatory Affairs (Associates, Specialists, Managers, Directors or VPs) o

Quality Professionals (Associates, Specialists, Managers, Directors or VPs)

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R&D (Engineers, Scientists, Managers, Directors or VPs)


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Complaint and Risk Management Personnel

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Consultants

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Contractors/Subcontractors

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CEOs

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VPs

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Clinical Affairs (Associates, Specialists, Managers, Directors or VPs) Other Interested Parties

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Wednesday, January 30, 2013 10:00 AM PST | 01:00 PM EST Live Session for one participant

Price: $243.00 Corporate Live Session 3 to 4 participants in single location. (For muliple location contact customer care)

Price:$486.00 Corporate Live Session 5 to 10 participants in single location. (For muliple location contact customer care)

Price:$986.00 Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months.

Price: $288.00


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