About the Course
Introduction to this course:
This course covers the key requirements of the US FDA medical device regulations for the manufacture, repackaging, relabeling, and/or import of medical devices and radiation-emitting products. It also covers the medical device classification in the US and other key concepts.
Who should attend:
This course is designed for professionals involved in the US medical device industry, particularly those in the development, and marketing of medical devices. The course is also suitable for anyone interested in understanding the medical device industry.
Learning Outcomes:
By the end of this lesson, you will be able to:
Identify key regulatory bodies and device classifications in the US
Consult the FDA classification database for medical devices
List common pathways to enter medical devices in the US
What will I gain:
Participants will gain a comprehensive understanding of the US FDA medical device regulations and an understanding of the process of developing and submitting regulatory documents for medical device approval.
Prerequisites:
Participants should have a basic understanding of medical device development and regulatory processes. Familiarity with quality management systems and international standards is beneficial.
Additional information:
Course duration: 00:25:35
Course code/version (effective date): L-146_A/v1.0 (20/09/2023)
Course Categories
-
US FDA Medical Device Regulations
- Lesson 1: Regulatory fundamentals of medical devices in the US (Part 1)
- Lesson 2: Regulatory fundamentals of medical devices in the US (Part 2)
- Lesson 3: Regulatory fundamentals of medical devices in the US (Part 3)
- Medical Devices: Risk-Based Classification for Patient Safety
-
Additional resources
- Mind map: Risk Management for Medical Devices
- Reading: How to classify your medical device in the US
- Reading: Food, Drug, and Cosmetic Act (FD&C Act)
- Reading: Guidance Document: Classification of Products as Drugs and Devices and Additional Product Classification Issues.
About the Course
Introduction to this course:
This course covers the key requirements of the US FDA medical device regulations for the manufacture, repackaging, relabeling, and/or import of medical devices and radiation-emitting products. It also covers the medical device classification in the US and other key concepts.
Who should attend:
This course is designed for professionals involved in the US medical device industry, particularly those in the development, and marketing of medical devices. The course is also suitable for anyone interested in understanding the medical device industry.
Learning Outcomes:
By the end of this lesson, you will be able to:
Identify key regulatory bodies and device classifications in the US
Consult the FDA classification database for medical devices
List common pathways to enter medical devices in the US
What will I gain:
Participants will gain a comprehensive understanding of the US FDA medical device regulations and an understanding of the process of developing and submitting regulatory documents for medical device approval.
Prerequisites:
Participants should have a basic understanding of medical device development and regulatory processes. Familiarity with quality management systems and international standards is beneficial.
Additional information:
Course duration: 00:25:35
Course code/version (effective date): L-146_A/v1.0 (20/09/2023)
-
US FDA Medical Device Regulations
- Lesson 1: Regulatory fundamentals of medical devices in the US (Part 1)
- Lesson 2: Regulatory fundamentals of medical devices in the US (Part 2)
- Lesson 3: Regulatory fundamentals of medical devices in the US (Part 3)
- Medical Devices: Risk-Based Classification for Patient Safety
-
Additional resources
- Mind map: Risk Management for Medical Devices
- Reading: How to classify your medical device in the US
- Reading: Food, Drug, and Cosmetic Act (FD&C Act)
- Reading: Guidance Document: Classification of Products as Drugs and Devices and Additional Product Classification Issues.
