Aethlon Medical Inc (AEMD)

[ANESRI]

http://www.q1productions.com/medicaldeviceapprovals/Index.php


Providing Clarity & Definition to New & Existing FDA Regulatory Pathways to Ensure Medical Device Approvals in a Timely & Cost Efficient Manner

December 8-9, 2011
Baltimore, MD

ABOUT THE CONFERENCE

The medical device industry is experiencing greater regulatory scrutiny from FDA; several instances of device failures and high profile recalls have resulted in the agency looking closer at devices on the market and their approval processes. Changes to popular approval routes such as the 510(k) are up for reconsideration. With budgets throughout the industry already stretched, changes to regulatory directives are causing confusion and concern, as indications point to more clinical research data being required, longer trials being conducted and longer times to market. This conference will provide clarity to new regulatory pathways for device approvals and regulatory oversight.

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TOPICS TO BE COVERED
Understanding Changes to the 510(k) Regulatory Process
Improving Transparency & Communication from the Agency to the Public
Achieving a Better Understanding of how FDA Scrutinizes Predicate Devices
Assurance Case Reports & its Impact on 510(k) Submissions
Comprehending FDA's Regulatory Approval Process for Combination Products
Using Pre-IDE Meetings to Streamline the IDE Process
Panel Discussion: Q&A Sessions with FDA Representatives
Evaluating Recent FDA Approvals
Exploring the Usefulness of the De Novo Process
Case Study: A Look at the Modular PMA Process
Navigating the Regulatory Process in Europe
Examining FDA Rules Governing Social Media
Reviewing Recent Enforcement Actions Regarding Off-Label Use
Examining the Latest Recall Cases in the Medical Device Industry
Investigating Trends in Warning Letters Issued by the FDA