REGU09002 2019 Introduction to US Medical Technology Regulatory Affairs

General Details

Full Title
Introduction to US Medical Technology Regulatory Affairs
Transcript Title
Introduction to US Medical Tec
Code
REGU09002
Attendance
N/A %
Subject Area
REGU - Regulatory Affairs
Department
LIFE - Life Sciences
Level
09 - NFQ Level 9
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Mary Butler
Programme Membership
SG_SMEDI_M09 201900 Master of Science in Science in Medical Technology Regulatory Affairs SG_SMEDI_O09 201900 Postgraduate Diploma in Science in Science in Medical TechnologyRegulatory Affairs SG_SMEDI_E09 201900 Certificate in Science in Medical Technology Regulatory Affairs
Description

This module is taken by Level 9 students in Medical Technology Regulatory Affairs. It aims to provide students with a detailed knowledge and understanding of the regulatory pathway for placing medical devices on the market in the US. It explains the legislation applicable and guidelines available to medical device manufacturers.

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

Demonstrate they have detailed knowledge and understanding of the US FDA regulatory process and structure.

2.

Source, review, analyse and interpret FDA Regulations, guidance documents, consensus standards, FDA forms .

3.

Illustrate an understanding of the steps required to achieve market clearance/approval for a 510(k), PMS, IDE and DeNovo application.

4.

Analyse requirements for device listing , establishment registration and post market surveillance

5.

 Critique and review the current and changing US regulatory environment in response to strategic industry needs and changing global regulatory environment.

Teaching and Learning Strategies

The educational elements will be provided by the Institute of Technology Sligo, NUI Galway and NIBRT staff. Additional lecturing, as required, may be provided by outside specialists and practitioners. Online/blended programmes are designed for students who want to study part-time at a pace that matches their work-life balance. Through a combination of blended delivery formats including online (synchronous and asynchronous) as well as other technologies we strive to reach the forefront of emerging breakthroughs in the delivery and assessment of online students.

Module Assessment Strategies

The module will be assessed on the basis of 100% continuous assessment. Some or all of the following assessment modes may apply: examinations, practical work, projects, essays, vivas, seminars, and assignments. These assessments may be organised at different centres throughout the country and a selection of assignments may be assessed.

Sample Technologies in use during assessments
• Moodle
• Adobe connect
• Turnitin
• Panopto
• Microsoft office
• Multimedia including DVDs, webinars, youtube video clips, online videos

Repeat Assessments

The programme allows students to progress to a next stage if they have failed to attain the pass mark for a particular module. A student may be allowed to carry up to 10 credits into a new stage. This policy is at the discretion of the examination board.

Indicative Syllabus

The following is a summary of the main topics included in this particular module: US FDA structure and function, administrative and legislative structure of the FD&C Act, regulatory pathway; classification; Consensus standards; regulatory pathways; QSIT; Post market surveillance requirements. Demonstrate they have detailed knowledge and understanding of how to define the regulatory pathway for medical devices including complex combination or novel devices.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Assignment written assignment Continuous Assessment Assignment 60 % Week 9 1,3,4,5
2 Case Study workshop scenarios (formative) Continuous Assessment Assessment 20 % Week 13 3,4,5
3 LAQ Continuous Assessment Open Book Exam 20 % Week 4 1,2,3

Part Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Online Lecture Not Specified Lecture 2 Weekly 2.00
Total Part Time Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Recommended Reading
2011-04-07 Medical Device Design and Regulation Quality Press
ISBN 0873898168 ISBN-13 9780873898164

The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a road map to the regulation of medical devices. It provides a broad understanding of the breadth and depth of medical device regulation by collecting in one textbook coverage of the regulatory scheme for medical devices in terms that are suitable for engineers, scientists, and healthcare providers. The vast amount of information available on the subject is distilled into a concise and coherent presentation. There also are problems and projects at the end of each chapter. In addition to the usual questions requiring specific answers, the projects include the drafting of a device control plan, the development of a nonclinical test procedure, the resolution of a recall, the response to a Warning Letter, and the creation of a CAPA for a device deficiency. A solutions manual for these exercises is available to teachers who adopt the textbook for classroom use. Medical Device Design and Regulation (MDDR) also makes available over 100 complimentary live hyperlinks to web pages with additional relevant information, and offers users the opportunity to join and participate in the MDDR Users Group on LinkedIn.

Recommended Reading
2014-01-23 FDA Regulatory Affairs: Third Edition CRC Press

FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more.


The Third Edition of this highly successful publication:




  • Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing

  • Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL

  • Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements

  • Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V

  • Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions


Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process thats broadly useful to both business and academia.

Module Resources

Non ISBN Literary Resources

http://www.fda.gov/ 

General web references include: 

FDA - Device Advice: 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm 

FDA Databases - useful for research : 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/defa 
ult.htm

Journal Resources

http://www.fda.gov/ 

General web references include: 

FDA - Device Advice: 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm 

FDA Databases - useful for research : 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/defa 
ult.htm

URL Resources

http://www.fda.gov/

General web references include:

FDA - Device Advice:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm

FDA Databases - useful for research :
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/defa
ult.htm

Other Resources

None

Additional Information

None