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FDA Approval Process for Medical Devices - Updated Programme Includes all the Current FDA Guidelines (Seminar, London)

DUBLIN, April 10, 2014 /PRNewswire/ --

Research and Markets (http://www.researchandmarkets.com/research/t45c8d/fda_approval) has announced the addition of the "FDA Approval Process for Medical Devices - Updated Programme Includes all the Current FDA Guidelines (Seminar, London)"conference to their offering. 

     (Photo: http://photos.prnewswire.com/prnh/20130307/600769 )

The FDA Approval Process for Medical Devices seminar will take place on the 19th & 20th May 2014 at The Rembrandt Hotel, London

This seminar will highlight new changes in the medical device regulations and provide an overview of the submission of documents to the FDA for approval of medical device products. Participants will gain a better understanding of the medical device approval process and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research will be provided, as well as information on the structuring of submissions and post-approval documents. Information on maintaining ongoing relationships with the FDA will also be discussed. Attendance at this seminar will enable delegates to provide the FDA with the necessary information to obtain product approval.

Upon completion of this seminar, participants will:

- Understand the FDA medical device approval system

- Know what is required for an Investigational Device Exemption (IDE)

- Learn the contents of a Post-Market Approval (PMA)

- Discover what to include in an annual report


This seminar is intended for Regulatory, Technical and Quality Personnel who require an understanding of the FDA medical device approval system. Management, Legal and other personnel who must be familiar with the essentials of the medical device approval process and submission of related documents will also benefit in attending.


Delegates will receive a course material folder containing comprehensive documentation provided by the speaker, which will be a valuable source of reference for the future.

A Certificate of Attendance for Professional Development will be given to each participant who completes each course


19 & 20 May 2014 


19 May 2014 Start 09.30 - Finish 17.00
20 May 2014 Start 09.00 - Finish 16.30


19 May 2014 09.00


The Rembrandt Hotel, 11 Thurloe Place, London SW7 2RS


Opposite V&A Museum. Nearest underground station: South Kensington.

NOTE: Events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged 

Key Topics Covered: 

PROGRAMME DAY ONE - 19 May 2014 

Introduction to FDA

- History and law
- Definitions
- Overview of FDA
- Establishment registration
- Product licensing

510(k) Process

- Substantial equivalence
- Letter of notification
- Truthful and accurate statements
- Cover page
- Table of contents
- Checklist for filing
- Executive summary
- Intended use
- Device description
- Table of comparison
- Similarities and differences
- Environmental testing
- Comparative performance
- Clinical performance
- Software
- Biocompatibility
- Voluntary standards
- Sterility
- Reusable or single-use device control
- Labelling
- Kit information
- 510(k) summary
- FDA 510(k) review


Investigational Device Exemption (IDE)

- Significant risk versus non-significant risk
- Sponsor
- Prior investigations and investigational plan
- Facilities and controls
- Investigator agreement
- Institutions
- Sale of device
- Environmental assessment
- Labelling
- Informed consent
- FDA actions on applications

Pre-Market Approval (PMA)

- Applicant
- Table of contents and summary
- Device description
- Standards
- Non-clinical studies and clinical studies
- One investigator
- Bibliography
- Samples
- Labelling
- Environmental assessment
- PMA amendments and PMA supplements
- FDA action on PMA
- Post-approval requirements 


Albert. A Ghignone, MS, RAC, FDA Regulatory, Quality and Clinical Consultant, AAG Incorporated, USA. He has spent more than 30 years in the pharmaceutical industry at Sterling Drugs, Carter-Wallace, Hoechst-Roussel, National Patient Development Corporation and Datascope Corporation. He has a background in pharmacy and dosage form development. 

His professional career has specifically focused in the areas ofregulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics and medical devices. In his various positions he was responsible for all regulatory submissions, registrations, FDA liaison and all compliance activities. He also has expertise in the assessment of product and facilities for the due diligence relative to FDA requirements. He lectures throughout the world on drugs, biologics, medical devices and FDA related matters. 

He is a member of the Regulatory Affairs Professional Society, which gave him the Professional of the Year award in 1984. He has served the society as Vice-President, President and Chairman of the Board of Directors. He is certified as both an ISO 9000 Lead Auditor and Regulatory Affairs Professional.

NOTE: Events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged

For more information visit http://www.researchandmarkets.com/research/t45c8d/fda_approval

About Research and Markets

Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Media Contact: Laura Wood , +353-1-481-1716, [email protected]

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