1. www.onlinecompliancepanel.com
Call: +1-510-857-5896
Fax: +1-510-509-9659
www.onlinecompliancepanel.com | 38868 Salmon Ter, Fremont, CA 94536
Webinar by Angela Bazigos
FDA Guidance Design Considerations for
Pivotal Clinical Investigations for Medical
Devices
[ Wednesday, 02 July 2014 | 10:00 AM PDT | 01:00 PM EDT ]
Description:
This webinar introduces FDA’s guidance "Design Considerations for Pivotal Clinical Investigations in Medical Devices" that was
published in late 2013. It discusses the regulatory considerations for clinical study design, and delves into the issues of bias and
variance that may impact the quality of the data obtained in the study, as well as the interpretation of the data.
Following that, it discusses way that are available to a medical device sponsor, for eliminating bias and variance, both in terms of
the study design and the requirements for the personnel that will design and run the studies. Finally, it touches on the study protocol
and statistical plan and discusses ways to use those to ensure the success of the study.
In November 2013 the FDA issued the Guidance "Design Considerations for Pivotal Clinical Investigations for Medical Devices" to
provide guidance to Industry, Clinical Investigators and Institutional Review Boards, on the study design principles relevant to the
development of medical device clinical studies. Even though this guidance is focused on is providing recommendations to sponsors on
how to design clinical investigations to support a PMA, sponsors who conduct clinical studies to support pre-market notification (510(k))
and de novo submissions may also rely on the principles in this guidance document.
Why Should you Attend:
Each year, insufficient evidence of the safety and effectiveness of a medical device caused from incorrect study design, results in
the delay or rejection of either the medical device application or studies conducted towards that application. This is very expensive for
the medical device sponsor who has to do additional work or redo existing work. It is also very expensive for the FDA (or other
regulatory authorities) who spend the time to review results from incorrectly designed studies.
To mitigate these issues and standardize the way industry design clinical studies, the FDA published the guidance "Design
Considerations for Pivotal Clinical Investigations in Medical Devices" in late 2013. The FDA’s goal in publishing this guidance is to help
device manufacturers select the appropriate trial design to:
Better support and improves the quality of safety & effectiveness data submitted to the agency
Lead to timelier FDA approval
Speed patients’ access to new devices

2. www.onlinecompliancepanel.com
Call: +1-510-857-5896
Fax: +1-510-509-9659
www.onlinecompliancepanel.com | 38868 Salmon Ter, Fremont, CA 94536
Webinar by Angela Bazigos
Objectives of the Presentation:
The Guidance
General Principles
Some Principles for the Choice of Clinical Study Design
Clinical Outcome Studies
Diagnostic Clinical Performance Studies
Sustaining the Quality of Clinical Studies
Summary
Q&A
Who can Benefit:
Clinical Trial Physician / Doctor
Manager to Senior Director of
Regulatory Affairs
Quality Assurance
Clinical Research
Data Management
Data Monitoring
Institutional Review Board
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