Industries: Medical Device

Overview of FDA Regulatory Compliance for Medical Devices

Course Director: Glenda Guest

Course Fee: $2150.00 Regular Registration / $1950.00 Early Bird (30 Days in Advance)

  Accreditation: ***RAPS Approved Course***

Course Description -

This course discusses the FDA's regulatory authority for approving medical devices prior to marketing and the compliance programs used in enforcing its authorities during the manufacture and post-marketing reporting systems. This medical devices compliance course also provides FDA strategies towards inspections of manufacturing sites, and compliance actions that may result from these inspections. The course provides the attendees with the most important regulatory resource materials needed to understand agency policies and enforcement actions.

Issues to be covered include:

  • Structure of the FDA and current FDA regulatory compliance practices - how to work with FDA investigators
  • The regulatory approval process – "what the FDA is looking for" in 510ks, PMAs and other pre-approval applications
  • The scope of FDA's compliance programs, policies and potential enforcement actions
  • Discussion of post-marketing notification and reporting programs
  • Strategies for development of an in-house compliance program for GMPs which ensure successful inspectional outcomes
  • Recent FDA enforcement statistics

Who Should Attend

This training course has been developed for those who are involved with ensuring regulatory compliance for medical devices. The course is primarily geared towards those who are new to industry or require a basic understanding of medical device regulatory compliance issues. This medical devices compliance training may be of interest to industry veterans who need refresher training on these topics.

Typical FDA regulatory compliance course attendees include those in:

  • Manufacturing
  • Regulatory Affairs
  • Product Design, Research and Development
  • Quality Assurance & Control
  • Medical/Marketing Personnel
  • Management of Medical Device Operations

Course Agenda

First Day


  • Objectives
  • Seminar overview

Introduction to FDA

  • FDA organization and key departments
  • Regulatory procedures manual
  • Compliance program – compliance policy guides and other documents
  • Regulatory history for devices
  • Regulations and applicable guides

Product Approval Processes

  • Classification of the device is key
  • Premarket notification
  • Premarket approvals
  • De Novo Reclassification
  • Investigational clinical studies

FDA Reporting Systems

  • Registration and listing
  • US vigilance system-MedWatch
  • Corrections and removals

Compliance System

  • Types of programs
  • Inspectional operations manual
  • Inspectional outcomes

Enforcement Tools and Actions

  • Types of actions
  • Warning letters, civil money penalties and criminalpenalties

Enforcement Statistics

  • Review and discussion of warning letters and other enforcement actions

Question and Answer Session

Second Day

Quality System Orientation – 21 CFR 820

  • QSR scope, definitions and requirements
    • Key elements – Management responsibilities, design controls, production & process controls, non-conformances and CAPA, controls of documents and records
  • ISO 13485 comparison to QSR

Quality System Inspection Technique (QSIT)

  • Approach
  • Objective
  • Key subsystems

Quality Risk Management

  • ISO 14971

Do's and Dont's

  • Risk areas you want to avoid
  • Staying away from red flag areas

Why Systems Fail

Question and Answer Session

Learning Objectives

This course is specifically focused on the law, regulations and policies set by the FDA for the pre-market approval, manufacture and post-marketing compliance of medical devices. The course content is designed to provide an in-depth understanding of the paths to obtaining agency approval; how the FDA performs inspections; the type of controls, systems and documentation they expect to see in place; and the variety of outcomes from each inspection. The course also covers the remedies available to show inspectors that manufacturing processes are in full compliance with quality system requirements.


"Exceptional! The course was perfect in regard to content which introduced me to FDA Medical Device Compliance." Roger B., Regulatory Compliance Engineer, Luxfer Gas Cylinders
"Good course. Gave me a handle on the issues of regulator compliance." Manan H., Clinical Regulatory Manager, Infinite Biomedical Technologies
"This course was very useful to me to get a better understanding of FDA and quality systems from the viewpoint of our clients. I feel my lab quality manager would benefit from this course greatly. I appreciated the knowledgeable examples that helped to explain concepts more situationally, rather than just explanation of topics. It was useful to wrap my head around brand new concepts.." Julia V., Area Manager - Medical Device Unit, Menasha Packaging Corp.
"OUTSTANDING!!! Excellent class, great delivery, awesome overview. Thank you!" Eugenia T., Sr. Manager, R. J. Reynolds
"The Course Director is extremely knowledgeable and a true subject matter expert. She presents the material in a pleasant way and with meaningful practical examples." Melissa N., Sr. Clinical Study Mgr., Allergan
"Very useful as an overview. I was able to get a good feel for the important issues from the FDA perspective." Kristen I., Assistant Manager, Business Development, Panasonic Shikoki Electronics
"Very good course to introduce me to the world of medical device regulation and compliance. The class size allowed for very good instructor/participant interaction." George P., Global Registration Manager
"This course provided a great overview of a number of different areas, all of which pertain directly or indirectly to my current position" Diana S., Compliance Specialist, Terumo Medical Corp.
"I feel like I have an understanding of the concepts from this course. Thank you so much!" Melissa M., Quality Technician, Apothecary Products, Inc.
"The course provided an excellent basic overview of FDA regulation. One of the best medical device training courses I have ever attended!" Ron B., Quality Manager, Johnson & Johnson
"The Course Director provided a wealth of information. Her expertise and extensive personal experience was valuable to teaching the class. She was available for questions and provided excellent examples." Heather D., Siemens Medical
"Course director was extremely knowledgeable. Presented subject matter with diagrams which provided extremely comfortable understanding." Jacqueline E., Update Specialist, Siemens Medical
"Excellent delivery; organization of materials. Instructor went above and beyond in course presentation and audience engagements. It was fantastic…thank you!" Stephanie S., RA Specialist III, Dentsply Specialty Materials
"This was a very good all-around course. It provides useful information for all levels of QA experience." Mary M., QA Supervisor, Skytron
"Being new to the medical device industry, this was a good overview from the regulatory perspective. The knowledge gained will enhance my daily activities." Lynda S., Quality, Manager, Documentation & Labeling, Teleflex Medical
"I've had this course director before and was very happy to have her again. She is very engaging and encourages participation. She is very knowledgeable and very professional. I hope to have her again in the future." Randy M., Quality Engineer, Orasure Technologies, Inc.

Frequently Asked Questions

What is the scope and breadth of Regulatory Submission information/training that will be covered in this course? It appears that the only topic that is truly submission-oriented in nature is the topic on Product Approval Process. Will additional understanding of submission guidances be discussed, or, is the true focus of the training on compliance with what you have already submitted?

The Product Approval Process section is a higher level overview of the types of approvals and to which devices they may be applicable. Specific instructions for each type of submission are NOT covered in the class.

What are some resources that can be utilized to remain current on FDA and industry activities and discussions?

LinkedIn provides connections to various medical device groups. Keywords "device" or diagnostic" can be used to begin the search. The FDA Inspections Group provides current content based on FDA inspections. CfPIE also has a LinkedIn Group which is a forum for professionals to share industry-active topics. The FDA Law Blog ( covers patent issues, drugs, and other issues outside of only medical devices.

RAPS | Regulatory Affairs Professionals Society CfPIE is a Regulatory Affairs Professional Society (RAPS) RA Professional Development provider.

CfPIE is committed to enhancing the ongoing professional development of regulatory affairs professionals and others through appropriate regulatory affairs learning activities and programs.  CfPIE has agreed to follow RAPS-established operational and educational criteria.  Click here for the list of courses reviewed and approved by RAPS.