May 05, 2021 - May 06, 2021
/ Global
Date: May 5th & 6th, 2021
Time: 10:30am -3:30pm ET
Location: Virtual
Language: English
Introduction
Gain a thorough understanding of regulatory affairs for medical devices and IVDs in the U.S. in this intensive, two-day online workshop. Regulatory experts will discuss the laws, regulations, and enforcement and agency structures regulating devices and IVD products. They will review advertising, labeling and promotion post-market, as well as compliance and enforcement requirements. The speakers will also cover FDA guidance, and options and strategies for FDA submissions.
Pricing Amounts & Deadlines
10 November 2020 – 4 April 2021: Early Bird $800.00 Member | $900.00 Nonmember
5 April – 28 April 2021: Regular $900.00 Member | $1000.00 Nonmember
Who Should Attend?
This workshop will benefit individuals who are new to the regulatory profession, entering the medical device industry, or changing companies and/or product lines or industry. The material will also be helpful to anyone studying for the RAC Devices exam.
Agenda
- FDA history
- FDA organization
- DICE role
Overview of Medical Devices and IVDS- Classification
- 513(g) and de novo
- PMA perspectives
- 510(k) perspectives
- IDE and HDE perspectives
- Clinical conduct perspectives
QSR/QMS and Design Control
- Medical device
- IVD Breakout
- Postmarket Compliance is No Easy Journey
- Complaint handling and management
- Understanding medical device reporting
- Corrections/Removals (recalls)
- Navigating an FDA Inspection and Aftermath
- The knock on the door
- Conduction inspection
- Close-out meeting
- Post-inspection and enforcement
- Advertising, Promotion and Labeling
- Label and labeling
- Claims substantiation
- Lessons learned from warning letters
- Disseminating information about unapproved devices
- Intended vs. off-label use
- Direct-to-consumer advertising
- Social media