FDA Medical Device Approval Process

Course Description

This web seminar provides an overview of the regulations and obligations of a sponsor and investigator in the development of a new device using FDA and ICH guidance — Investigational Device Exemption (IDE) and abbreviated IDE processes. This is done by reviewing sponsor and investigator obligations, along with the principles of Good Clinical Practice (GCP). Definitions used by sponsors and regulatory authorities for device development will be reviewed. Participants will become familiar with the regulatory decision-making process used by the FDA and learn to navigate the approval pathways to market.  

Learning Objectives

• Discuss the FDA regulations and practical application of sponsor and investigator obligations defined in 21CFR812
• Describe the structure, purpose, and practical application of the ICH Guideline and its principles of GCP
• Describe the technical standards defined in ISO
• Define common terms used in device research
• Describe the three decisions in device development (classification, equivalence, and risk)
• Define the two pathways to market (PMA and 510(k))
• Navigate the FDA approval process
• Describe what an IDE and PMA are, identify their contents, and discuss the FDA review process

Who Should Attend

• Clinical Research Managers
• Principal Investigators
• Regulatory Associates
• Quality Assurance Personnel
• All other personnel responsible for the device approval process

Instructor

Shana Zink, B.S., C.C.R.A.

Click here for complete trainer biographies

Registration Fees

$735

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-24-017-L99-P. Released: 2/24. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.