Full Title US Medical Technology Regulatory Affairs Advanced

Short Title US MedTech RA Advanced

Code REGU09008
Level 09
Credit 05

Author Butler, Mary
Department Life Sciences

Subject Area Regulatory Affairs
Attendence N/A%
Fee

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, the essential requirements of devices, submission types, change control and emerging technologies.

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; emerging technologies.

Learning Outcomes
On completion of this module the learner will/should be able to
  1. Demonstrate they have detailed knowledge and understanding of the submission types involved by completion of mock submission documentation from classification through to commercialization.

  2. Formulate and communicate judgements with regard to regulatory decision making process for devices and demonstrate ability to interact effectively with FDA agents.

  3. Analyse and evaluate data from US FDA MAUDE (Manufacturer and user facility device experience) database.

  4. Communicate a detailed knowledge and understanding of how to manage change control for a product destined for US market.

  5. Source and interpret relevant reimbursement requirements.


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

Assessment Facilitites
Moodle access

Module Dependencies
Pre Requisite Modules
None
Co Requisite Modules
None
Incompatible Modules
None

Coursework Assessment Breakdown %
Course Work / Continuous Assessment 100 %

Coursework Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week
Assignment written assignment 3,4,5 60 Week 7
Case Study workshop scenarios (formative) 3,4 20 Week 13
LAQ 1,2,3 20 Week 3


End Exam Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week


Distance Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Part Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload
Online Lecture Not Specified Lecture 2 Weekly 2.00

Total Average Weekly Learner Workload 2.00 Hours

Full Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Online Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload
Independent Learning Online Independent Learning 5 Weekly 5.00

Total Average Weekly Learner Workload 0.00 Hours

Resources
Book Resources

Other Resources
None
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
Additional Info

ISBN BookList

Book Cover Book Details
Carl T. DeMarco 2011 Medical Device Design and Regulation Quality Press
ISBN-10 0873898168 ISBN-13 9780873898164
2014 FDA Regulatory Affairs: Third Edition CRC Press
ISBN-10 ISBN-13