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. How changes are addressed with each format. Such issues are taking on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do to "toughen" the new product review process -- all of which is being demanded by a public tired of on-going news of new product failures. A review of recent information from the Agency, as well Agency steps that have already been translated into action in the past two years will provide direction in areas of concern and what to expect in the future.

Why should you attend: The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process, others are exempt, and some must go through the extremely costly, time consuming and rigorous PMA approval process. The FDA holds companies responsible for filing new 510(k)s, or IDEs / PMAs when new products are to be marketed in the U.S., or when existing products and/or their Indications for Use are changed. What are the steps and how are they documented? How is 510(k) vs PMA determined. What should be included, and what should only be referenced. What new concerns need to be addressed now? How can companies make such determinations? What approaches are required for product changes; for process changes? What about software "in-" or "as-product"? How does ISO 14971 Risk Management fit into the clearance / approval process? How to maximize the compilation process against scarce resources.

Areas Covered in the Session:
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
Clinicals -- the 'basics'
The PMA -- Pre-market Approval
Resolving a "Wrong" Decision

Who Will Benefit:
Senior management in Devices and Combo Products
QA
RA
R&D
Engineering
Production
Operations
Consultants

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, world wide. 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.

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com