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    Live event FDA 510(k):Putting Together a Compelling 510(k) for Submission:Dos and Don't s

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    Website https://compliance2go.com/product/?pid=CP2014-422 | Want to Edit it Edit Freely

    Category Biotechnology ;Healthcare ;Medical Device ;Pharmaceutical

    Deadline: February 23, 2015 | Date: February 24, 2015

    Venue/Country: Online, U.S.A

    Updated: 2015-01-23 17:51:56 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    This webinar is intended to discuss how to put a 510(k) package with improved awareness and familiarity.

    The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) prescribes the premarket notification requirements. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs). The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device(s) (predicate device) as described in 21 CFR 807.92(a)(3). In other words, firms 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 how to expedite the FDA review process leading to a prompt clearance.

    At the end of this webinar, you will become better aware of the FDA 510(k) contents for submission including what to dos and what not to dos. As a result, you will be able to develop your own practical, actionable and sustainable approaches for your successful 510(k) submission and clearance.

    Why should you attend :

    This webinar is intended to provide you with how to best put a compelling 510(k) package for submission including Dos and Don’ts.

    Areas Covered in the Session:

    Statute(S) And Regulations Including Recent Amendments.

    Definitions

    Medical Device Classification Including IVDs

    510(k) Process

    Selecting Predicate Device(s)

    De Novo Process ? Practical Advice

    How To Demonstrate Substantial Equivalence

    510(K) Contents And Format

    510(k) Preparation: Dos and Don’ts

    Addressing Technical And Regulatory Requirements

    510(k) Submission Quality For A Product-Be Aware

    Responding to FDA’s Request Of Additional Information.

    Resolving Different Opinions Between The Submitter And FDA Reviewer(S).

    Avoiding Common Mistakes with Awareness

    510(k) Trends

    Best Practices

    Speaker’s PASS-IT Recommendations

    Who will benefit: (Titles)

    Regulatory Affairs Managers, Directors and VPs

    Clinical Affairs Personnel (Coordinators, Monitors, Managers, Directors, and VPs)

    R&D Scientists, Engineers, Managers, Directors, and VPs

    Quality Engineers, Managers, Directors, and VPs

    Compliance Officers and Legal Counsel

    Complaint Handling and Risk Management Managers and Directors

    Clinical investigators and CRO Employees

    Consultants

    Senior and Executive Management

    Anyone Interested in the 510(k) Submission

    Webinar Includes:

    Q/A Session with the Expert to ask your question

    Copy of PowerPoint slides (PDF print only)

    60 Minutes Live Presentation

    Certificate of Attendance


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.