Roadmap to Market - Step 2, US and the FDA

Roadmap to Market - Step 2, US and the FDA

Basic Level | English | Medical Device | 31 minutes

Corresponds to ½ day of teacher-directed learning

Description

Roadmap to Market is a training in recognizing basic regulatory vocabulary and introduction to relationships between some regulatory terms & concepts that govern Medical Device manufacture within the EU and US.

There are several courses in this series, take them step by step to become more comfortable in your role as a Regulatory affairs professional.

  1. Step 1 Roadmap to Market - EU
  2. Step 2 Roadmap to Market - US (this course)
  3. Step 3 Roadmap to market - Medical device QMS Introduction
  4. Step 4 Roadmap to market - Design and development
  5. Step 5 Roadmap to market - Software as a Medical device
  6. Step 6 Roadmap to market - Post market Surveillance

Content

  • Similarities and differences in definition, US vs EU?
  • Introduction Regulatory process for Medical Devices in the US
  • Risk classification and risk-based regulatory pathways
  • Build in quality during development and document it in Design History File
  • When FDA requires Post-Market Surveillance
  • Introduction to useful resources on FDA website

Course modules

0. Introduction

Here we introduce the fact that things are similar but not identical in the US compared to the EU.

Duration: 2 minutes (Total duration of the course: 31 minutes)

1. Exercise booklet - Roadmap to market US and the FDA

A brief explanation how to work with the exercises and the booklet.

Trainer: Faisal Kamal
Duration: 1 minute (Total duration of the course: 31 minutes)

2. What is a Medical Device?

Medical Device definition – comparison US to EU. Classification. How the US FDA regulates Medical devices. Different pathways to the US market. After this section, there is an extra task described in the booklet. The task will be included in the questions to verify your knowledge.

Trainer: Faisal Kamal
Duration: 10 minutes (Total duration of the course: 31 minutes)

3. MMAs, SaMD & Accessories

How Mobile Medical Apps and Software as a Medical Device are regulated. Introduction to the concept of accessories.

Trainer: Faisal Kamal
Duration: 5 minutes (Total duration of the course: 31 minutes)

4. Quality is always KeyTry it!

Introduction to 21 CFR 820, Quality System Regulation/CGMP for Medical devices. Quality is built in during design and development. After this section, there is an extra task described in the booklet. The task will be included in the questions to verify your knowledge.

Trainer: Faisal Kamal
Duration: 2 minutes (Total duration of the course: 31 minutes)

5. Controlling the outcome

How regulatory requirements are differentiated depending on risk. Different regulatory pathways for different risk classes. After this section, there is an extra task described in the booklet. The task will be included in the questions to verify your knowledge.

Trainer: Faisal Kamal
Duration: 2 minutes (Total duration of the course: 31 minutes)

6. Design History File

The importance of documenting the development activities. When FDA require Design controls and when exemptions apply. After this section, there is an extra task described in the booklet. The task will be included in the questions to verify your knowledge.

Trainer: Faisal Kamal
Duration: 2 minutes (Total duration of the course: 31 minutes)

7. The product is out, but the work continues

FDA perspective on Post-market Surveillance.

Trainer: Faisal Kamal
Duration: 2 minutes (Total duration of the course: 31 minutes)

8. Staying current is critical

FDA concept of Recognized Consensus Standards. After this section, there is an extra task described in the booklet. The task will be included in the questions to verify your knowledge.

Trainer: Faisal Kamal
Duration: 3 minutes (Total duration of the course: 31 minutes)

9. Summary

Summary of the course. Understanding why definitions and reading requirements in detail is important. After this section, there is an extra task described in the booklet. The task will be included in the questions to verify your knowledge.

Trainer: Faisal Kamal
Duration: 2 minutes (Total duration of the course: 31 minutes)

Course material

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Notes

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Training organisation

The course results in a diploma that shows that you have the skills required.


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