FDA`s Medical Device Clinical Trials Program 2017

Topics

• Valid scientific evidence
• Introduction
• Significant/non-significant risk
• Phases of device human studies
• Exemption from IDE rules
• IDE meaning, content, review
• QSR design control integration
• Labeling/charging for product
• Post marketing studies product. Such knowledge might be
• Expanded access
• Understanding of limitations, evidence of clinical usefulness, or
• Required to enable the development of user instructions, better
• Why should you Attend:
• Elements of product design that require additional changes
• Clinical trials regulations (published 25 years ago), many
• In spite of the long experience device companies have with
• Only thing more expensive than a good clinical trial is a bad
• Companies have found this area an expensive trap. In fact, the
• The thought and experience that goes into a trial design. The
• Clinical trial. The probability of a successful trial is a function of
• By outside consultancies, such as CROs, but the experience has
• Thought, organization, compliance and analysis can be assisted
• Works, what its limitations are, what the company wants it to
• To be internal, a deep knowledge of the particular device, how it
• Areas Covered in the Session:
• Do, and the likelihood of its performing as desired
• Valid scientific evidence
• Introduction
• Significant/non-significant risk
• Phases of device human studies
• Exemption from IDE rules
• IDE meaning, content, review
• QSR design control integration
• Labeling/charging for product
• Post marketing studies
• Expanded access
• R&D and Regulatory Staff
• Who Will Benefit:
• Speaker Profile:
• Management of R&D Regulatory
• Law firm, Longwell and Associates, which specializes in Food
• Anna Longwell is currently principal attorney of the Palo Alto
• Regulation and law, affecting the development and ultimate
• And Drug law. The firm has expertise in US FDA expectations
• Biologics
• Marketing of new medical products, drugs, devices and
• Compliance4All DBA NetZealous
• Contact Detail:
• Email: support@compliance4All.com
• Phone: +1-800-447-9407
• Event Link : http://bit.ly/2aWhBD3
• Http://www.compliance4all.com/
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Who should Attend

• Management of R&D Regulatory
• R&D and Regulatory Staff