Meet the U.S. FDA's Tougher Requirements for the 510(k) - Webinar By GlobalCompliancePanel

							GlobalCompliancePanel                                                Your Gateway to Regulatory Compliance

Live Webinar on

Meet the U.S. FDA's Tougher Requirements for the 510(k)

Date: Wednesday, March 20, 2013                                      Time: 10:00 AM PST | 01:00 PM EST

Duration: 90 Minutes            Location:   Online          Instructor: John E Lincoln

Course "Meet the U.S. FDA's Tougher Requirements for the 510
(k)" has been pre-approved by RAPS as eligible for up to 1.5 credits               Register Now
towards a participant's RAC recertification upon full completion.


Overview:
This webinar will evaluate medical device review routes under Exempt, 510(k) / PMN, and PMA, as
both a process and as documentation / submissions. The 510(k) process and submission
documentation, the role of the IDE, and the PMA process and submission documentation will be
evaluated and discussed.

The 21 elements of the 510(k). What is an IDE, and what is its format and role. The tailored FDA
approach to the PMA. The broad range of U.S. FDA / regulatory issues to be considered by a
company approaching the introduction of a new or changed device will be discussed, whether
domestically manufactured or imported.


Areas covered in the session:

    l   Tougher Expectations / Requirements
    l   The 510(k) - Pre-market 'notification' and FDA Device Clearance
    l   Predicates and Substantial Equivalence
    l   Intended Use / Indications for Use
    l   The IDE - Investigational Device Exemption; IRB's; Disclosures
    l   Clinical - the 'basics'
    l   The PMA - Pre-market Approval
    l   Resolving a "Wrong" Decision



Who Will Benefit:                                        About Speaker

                                                         John E Lincoln
    l   Senior management in
                                                         Consultant, Medical device and
        Devices and Combo                                Regulatory affairs,
        Products                                         John E. Lincoln is a medical device
    l   QA                                               and regulatory affairs consultant. He
    l   RA                                               has helped companies to implement
                                                         or modify their GMP systems and
    l   R&D                                              procedures, product risk
    l   Engineering                                      management, U.S. FDA responses. In
    l   Production                                       addition, he has successfully
                                                         designed, written and run all types of
    l   Operations
                                                         process, equipment and software
    l   Consultants                                      qualifications/validations, which have
                                                         passed FDA audit or submission
                                                         scrutiny, and described in peer-
                                                         reviewed technical articles, and
                                                         workshops, world wide.   ...more

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