FDA Guidance Design Considerations for Pivotal Clinical Investigations for Medical Devices

Duration: 90 Minutes
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.
Design Considerations for Medical Devices
Instructor: Angela Bazigos
Product ID: 500320

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
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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  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.

Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.

More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She was on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Lifesciences industry.
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