RAPS pre-approved webinar on "Meet the U.S. FDA's Tougher Requirements for the 510(K)" from GlobalCompliancePanel

Top Quote "Meet the U.S. FDA's Tougher Requirements for the 510(K)" is the topic of a RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on March 20. End Quote
  • Fresno, CA (1888PressRelease) March 20, 2013 - Description:
    The 510 (K) submission is a crucial step towards getting FDA approval for medical devices. A majority of devices are cleared by the FDA under the 510 (K) process. For a few types of medical devices; no approval is needed. For other types of devices, a very stringent, expensive and laborious PMA approval process has to be passed.

    Companies are held responsible by the FDA for filing new 510(K)'s, or IDEs/PMAs, both when new products are to be marketed in the U.S., and when existing products and/or their Indications for Use are changed. This webinar will lay out all the details of what steps need to go into this, and how they need to be documented. It will discuss issues like how a 510(K) vs. PMA is determined.

    It will also cover aspects like what all need to be included, and what all should only be referenced. With the passage of the FDA's August 2010 510(K) study and resulting January 2011 Report, some new concerns have arisen. This webinar will discuss what these are and how they need to be addressed now. There is an added urgency for looking into these elements, since the FDA has tightened its expectations for a host of medical device requirements.

    This session will also take up for discussion the three types of 510(K)'s and when they have to be used. It will also cover the 21 mandatory elements that need to be addressed. It will cover the following areas:
    - Tougher Expectations/Requirements
    - The 510(K) -Pre-market 'notification' and FDA Device Clearance
    - Predicates and Substantial Equivalence
    - Intended Use/Indications for Use
    - The IDE -Investigational Device Exemption; IRB's; Disclosures
    - Clinical -the 'basics'
    - The AMP -Pre-market Approval
    - Resolving a "Wrong" Decision

    When: March 20, 10:00 AM PDT | 01:00 PM EDT

    By whom:
    John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, worldwide.
    John has also managed pilot production, regulatory affairs, product development/design control, 510(K) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

    For whom:
    - Senior management in Devices and Combo Products
    - QA
    - RA
    - R&D
    - Engineering
    - Production
    - Operations
    - Consultants

    Duration: 90 minutes

    To enroll for this webinar, contact
    webinars ( @ ) globalcompliancepanel dot com
    Phone: 800-447-9407

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