Writing Assignment #1
RGA6212 Spring 2022: Executive Summary – Overview of the Basics of
Pre-market Medical Device Reporting Requirements
Assignment specifications:
• ASSIGNMENT AVAILABLE: 25 April 2022 (Week 3)
• ASSIGNMENT DUE: May 18, 2022, 11:59 PM
• ASSIGNMENT LENGTH:
◦ 5-7 written pages (or more, if needed, but not to exceed 10) but NOT
Including figures or tables or references
• DELIVERY TO INSTRUCTOR: Via Canvas link for Written Assignment #1
• GRADE PERCENTAGE: 10.0%
Assignment description:
In completing Writing Assignment #1 for RGA6212 students will have the opportunity to:
• Simulate the role of a Regulatory Affairs Manager in identifying the key
differences between pharmacovigilance practices for drugs/biologics vs. medical
devices
• Demonstrate understanding of the relevant Safety Reporting guidelines for drugs
and devices in the US and EU, specifically
• Apply knowledge of the relevant Safety Reporting regulations for drugs,
biologics, and devices in a real-world setting
You are a Sr Manager of Regulatory Affairs at a small, emerging biotechnology
company that is looking to develop a new medical device for the treatment of atrial
fibrillation, also known as irregular/rapid heartbeat. To-date, your company only has
experience with the pharmacovigilance practice related to the development of drugs/
biologics. Your device is similar to a pacemaker in that it is an implantable electronic
device that will be placed in a certain location within the heart muscle of a patient and
will be left there for several years to regulate the heartbeat.
Your company is preparing to embark on medical device trials in the United States and
Spain.
Your task is to provide the following information to your colleagues in the form of an
executive summary (incorporation of figures and graphs HIGHLY encouraged):
- Introduction (1 paragraph)
- Provide a general introduction for your colleague to explain the purpose of
this briefing document and what types of information you plan to include
and why. - Outline the Key Players (2-3 paragraphs)
- Regulatory Oversight for Devices: In each of the 2 countries (US,
Spain), what regulatory bodies are tasked with providing direct oversight
to: - Medical Device pre-market development
- Medical Device Pharmacovigilance – hint: In Spain, you will need to
address this on two levels: The European Commission’s role and
the role of The Spanish Agency of Medicines and Medical Devices
(AEMPS) - FDA Medical Device Requirements (3-4 paragraphs)
- Describe the different FDA classifications for medical devices. Be
sure to clearly outline how risk plays a role in the classification of
devices and explain why your company’s device, which is intended
to regulate the heartbeat, will most likely be classified as a Class III
device. - Identify and outline, in your own words, the key areas under the
Code of Federal Regulations that pertain to pre-market medical
device pharmacovigilance as conducted under an Investigation
Device Exemption (IDE). - What types of medical devices fall under this part of the
code? - What are the pharmacovigilance/safety-relevant concepts
introduced in the code?
• What safety-related definitions are introduced that are different from what your
company is used to seeing with drugs/biologics? - What are the expedited reporting details? What events meet these criteria and
what are the timeframes? - European Commission Device Requirements (3-4 paragraphs)
- Describe the different EC classifications for medical devices. In what ways
are they similar or different from those employed by the FDA? Be sure to
clearly outline how risk plays a role in the classification of devices and
explain why your company’s device, which is intended to regulate the
heartbeat, will most likely be classified as a Class III device. - Identify and outline, in your own words, the key areas under the EU MDR
that pertain to pre-market medical device clinical investigations: - What are the pharmacovigilance/safety-relevant concepts
introduced in the EU MDR? - What safety-related definitions are introduced that are different from
what your company is used to seeing with drugs/biologics?
• What are the expedited reporting details? What events meet these criteria and
what are the timeframes, if any? - Optional: While Spain is an EU member state and therefore comes under the EC
medical device rules, what role with Spain’s Competent Authority, The Spanish
Agency of Medicines and Medical Devices (AEMPS), play with respect to safety
reporting for the medical device while it is undergoing clinical trials in Spain - Conclusion/Next Steps (1-2 paragraphs)
- What resources will you use to help your company understand the
pharmacovigilance regulations related to clinical trials of medical devices
in the US and EU? - Will you recommend any specific vendors to help manage safety reporting
during clinical trials of your device? Feel free to take this in a creative
direction
The entire assignment should be 5-7 written pages (or more, if needed, but not to
exceed 10) but NOT Including figures or tables, or references. Any graphs or figures
that you choose to include must be properly cited and do not count against your page
count. Please submit your assignment through the link provided in Canvas. Please
remember that this assignment is worth 10.0% of your final grade for the course. Late
submissions will not be accepted without prior permission from the Instructor.