I’m working on a pharmacology case study and need a sample draft to help me learn.
Writing Assignment #2RGA6212 Spring 2021: Executive Summary – Overview of the Basics of Pre-market Medical Device Safety Reporting RequirementsAssignment specifications:ASSIGNMENT AVAILABLE: Week 6ASSIGNMENT LENGTH:4-6 written pages including references but NOT Including figures or tables, double-spaced
DELIVERY TO INSTRUCTOR: Via Canvas link for Written Assignment #2 provided under the Module 9/Week 9 sectionGRADE PERCENTAGE: 15.0%
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 safety reporting practices for drugs/biologics vs. medical devices
Demonstrate understanding of the relevant Safety Reporting guidelines for drugs and devices in the US, specifically
Apply knowledge of the relevant Safety Reporting regulations for drugs, biologics, and devices in a real-world setting
As with assignment #1, 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/safety reporting practice related to the development of drugs/biologics, so the world of medical device safety reporting is new to you.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 ONLY. Your job is to describe medical device safety reporting requirements so that your clinical operations team will be able to comply with safety reporting guidelines set forth by CDRH during their clinical investigations of this novel medical pacemaker device.Your task is to provide the following information to your colleagues in the form of an executive summary (Incorporation of relevant figures and graphs HIGHLY encouraged): Introduction (1-2 paragraphs)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.
Describe some of the ways in which medical device safety monitoring is different from safety monitoring/pharmacovigilance for drugs/biologics.
FDA Medical Device Requirements (4-5 paragraphs)Describe the different FDA classifications for medical devices. Be sure to clearly outline how risk plays a role in the classification of devices.
Describe the likely classification of your company’s pacemaker and subsequently, what, if any, clinical investigations will be required. Do you need an IDE?
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 for IDE reporting are introduced that are different from what your company is used to seeing with drugs/biologics being investigated under an IND?
What are the expedited reporting details for Medical Device Reporting to FDA?
What events meet these criteria and what are the timeframes?
Conclusion/Next Steps (2-3 paragraphs)What resources will you use to help your company understand the IDE reporting regulations related to clinical trials of medical devices in the US?
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.
We will review this assignment in week 7 and I am available by email to answer any questions you have regarding the assignment.The entire assignment should be 4-6 pages of content (including 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 15.0% of your final grade for the course. Late submissions will not be accepted without prior permission of the Instructor.
