REGU08004 2017 Fundamentals of US Medical Device Regulations

General Details

Full Title
Fundamentals of US Medical Device Regulations
Transcript Title
US Med Dev Regs
N/A %
Subject Area
REGU - Regulatory Affairs
LIFE - Life Sciences
08 - NFQ Level 8
05 - 05 Credits
Start Term
2017 - Full Academic Year 2017-18
End Term
9999 - The End of Time
Mary Butler
Programme Membership
SG_SMEDI_E08 202100 Certificate in Science in Medical Device Regulatory Affairs and Quality SG_SMEDI_L08 202100 Higher Diploma in Science in Medical Device Regulatory Affairs and Quality

This module aims to provide students with an introduction to and a fundamental understanding of current US legislation as it applies to medical devices and to provide students with an understanding of the US FDA classification system and potential regulatory pathways for placing medical devices on the market in the US. It also aims to provide the students with an understanding of the utilisation of standards and FDA guidance documents.

Learning Outcomes

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


Describe the evolution of current legislation


Classify a medical device under US requirements


Analyse key guidance documents and consensus standards and key FDA medical device databases


Define an appropriate regulatory pathway for a number of device classifications


Make change control assessments for common change types


Identify the key documents required in technical documentation to support a US regulatory submission


Evaluate how to interact effectively with FDA agents/reviewers


Evaluate the basics of US QSRs, PMS Requirements and Vigilance Requirements and navigate the US FDA MAUDE database

Teaching and Learning Strategies

Content will be delivered primarily via online and blended methods. Additional lecturing, as required, may be provided by outside specialists and practitioners. Learning strategies including evidence based and enquiry based learning also will be used.  Resources used will include Moodle, Adobe connect, Panopto, and other multimedia such as youtube, webinars, literature databases.

Module Assessment Strategies

The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQ's, project assignments, group reports and essays and oral presentations.

Repeat Assessments

Repeat assignments will be given.

Indicative Syllabus

The following is a summary of the main topics included in this particular module: 

  • The history of medical device regulation in the US, the US FDA administrative and legislative structure (FD&C Act) and requirements
  • How to determine device classification
  • Outline of key facets of US regulation such as “substantial Equivalence and the sue of consensus standards
  • Outline of regulatory pathways and key submission types, 510(k), PMA, De Novo etc.
  • How to source and use appropriate guidance documents
  • How to manage change control
  • Best Practices in the preparation of Submission Documentation

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Technical report Continuous Assessment Written Report 20 % Week 3 1,6,7,8
2 Essay Continuous Assessment Essay 30 % Week 6 2,3,5
3 MCQ/LAQ Continuous Assessment Multiple Choice 15 % Week 10 4,5,8
4 Critical evaluation Continuous Assessment Written Report 25 % Week 8 4,6
5 Presentation Continuous Assessment Oral Exam 10 % Week 13 3,6,7

Online Learning Mode Workload

Type Location Description Hours Frequency Avg Workload
Online Lecture Online Lecture 2 Weekly 2.00
Independent Learning Online Independent Learning 5 Weekly 5.00
Total Online Learning Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Recommended Reading
2014-02-28 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.

Recommended Reading
2011-03-07 Medical Device Design and Regulation ASQ Quality Press

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.

Module Resources

Non ISBN Literary Resources

as per book list