FDA Regulations
A Comprehensive View of FDA Regulations for Medical Devices 2020
Important Dates
About FDA Regulations
Cover more than just the Quality Management System Provide an overview of regulations and how they fit together Explain Unique Device Identification (UDI) in detail, covering the issues device manufacturers will face as well as timeline for implementation Help attendees understand the four major elements of the US regulatory structure: laws, regulations, guidance, and consensus standards Teach the current device marketing regulations Discuss how to handle FDA inspections and effectively respond to inspectional observations and 483s
Call for Papers
In the US, medical devices organization uses risk classes and panels. Devices fall under regulations and product codes that determine the available conformity assessment paths and provide requirements for specific cases.
The Quality System Regulation, in Part 820, provides the quality management system required for medical devices in the US. Device design, production, installation, and servicing fall under Part 820. This part of the regulations include management responsibility for the system, design requirements, purchasing, manufacturing processes and controls, release for distribution, record keeping, etc. After release, a device is subject to a variety of other requirements ranging for complaint management to medical device reports to recalls. Each of these requirements is in a separate part of the regulations.
This two day highly interactive seminar will provide attendees a comprehensive view of the U.S. medical device regulatory requirements and will help them understand the whole picture and provide them with the effective implementation techniques for their organizations.
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