Training and Continuing Education

2015 Case Studies

  1. Regulatory Pathways for Medical Devices: Choosing the Right One
  2. Freedom From Unacceptable Risk: Making a Case for Safety Assurance and Risk Management
  3. Bringing an Innovative Device to Market: Premarket Approval (PMA) of Medical Devices
  4. An innovative "Me-Too" Idea: Premarket Notification - 510(k) Medical Device Submissions
  5. Regulatory Pathways for Pediatric Medical Devices: Marketing a Pediatric Medical Device via a Humanitarian Device Exemption
  6. Using the De Novo Process to Classify and Bring to Market an Innovative, Low-to-Moderate Risk Device
  7. Seeking early feedback from FDA through the pre-submission program
  8. The Investigational Device Exemption (IDE) Process: When is an IDE the right choice?

1) Regulatory Pathways for Medical Devices: Choosing the Right One

DOCUMENTS:

DESCRIPTION:

A fledgling company works to bring its first product to market.  This fictionalized case study explores the regulatory pathways for medical devices.

Learning Objective(s):

  1. To review the fundamental concepts of premarket regulatory activities of medical devices in the United States.
  2. To apply the regulatory concepts to an infusion device.
  3. To identify the available regulatory pathways for medical devices.

Subjects Covered:

  • Medical device definitions
  • Device classifications
  • Medical device regulatory pathways
  • Federal Food, Drug, and Cosmetic Act (FD&C Act) Chapter V: Drugs and Devices
  • FD&C Act 12 U.S.C. § 360c(a)(1), section 513(a)(1) Classification of Devices Intended for Human Use

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2) Freedom From Unacceptable Risk: Making a Case for Safety Assurance and Risk Management

DOCUMENTS:

DESCRIPTION:

An infusion pump company considers risk assessment and mitigation.  This fictionalized case study explores the development of a safety assurance case and risk management plan for an infusion pump device.

Learning Objective(s):

  1. To review the regulatory background of the safety assurance case.
  2. To identify fundamental concepts of safety assurance for medical devices.
  3. To explore how a risk management framework may support a safety assurance case.
  4. To apply the framework to risk assessment and risk control for an infusion device.  

Subjects Covered:

  • ISO 14971
  • Safety
  • Risk
  • Harm
  • Hazard
  • Hazardous situation
  • Code of Federal Regulations, Title 21, Parts Covered:
    • 21 CFR Part 807 Establishment, Registration, and Device Listing for Manufacturers and Initial Importers of Devices
    • 21 CFR Part 820 Quality Systems Regulation
    • 21 CFR Part 860 Medical Device Classification Procedures

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3) Bringing an Innovative Device to Market: Premarket Approval (PMA) of Medical Devices

DOCUMENTS:

DESCRIPTION:

A stent company seeks to market a novel medical device.  This fictionalized case study covers regulatory issues raised when bringing a bare metal coronary stent device to market through the Premarket Approval (PMA) regulatory pathway.

Learning Objective(s):

  1. To introduce the medical device First in Human (FIH) Investigational Device Exemption (IDE) Application.
  2. To introduce the medical device PMA.
  3. To understand the steps to obtain a PMA application and its data requirements.
  4. To examine the general principles of nonclinical and clinical investigations.
  5. To apply the learned concepts on a bare metal coronary stent system.  

Subjects Covered:

  • IDE
  • pre-IDE
  • PMA
  • Quality System Regulation (QSR)
  • Current Good Manufacturing Practices (CGMP)
  • Good Laboratory Practices (GCP)
  • Code of Federal Regulations, Title 21, Parts Covered:
    • 21 CFR Part 11 Electronic Records and Signatures
    • 21 CFR Part 50 Protection of Human Subjects
    • 21 CFR Part 54 Financial Disclosure
    • 21 CFR Part 56 Institutional Review Boards
    • 21 CFR Part 812 Investigational Device Exemptions
    • 21 CFR Part 814 Premarket Approval of Medical Devices
    • 21 CFR Part 820 Quality System Regulation

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4) An innovative “Me-Too” Idea: Premarket Notification - 510(k) Medical Device Submissions (PDF - 592KB)

DOCUMENTS:

DESCRIPTION:

A hip implant company seeks to market a medical device that it believes is substantially equivalent to a Class II medical device and  thus eligible  for the Premarket Notification (510(k)) regulatory pathway.  This fictionalized case study covers regulatory issues raised when bringing a hip implant device to market through the 510(k) regulatory pathway.

Learning Objective(s):

  1. To understand the “substantial equivalence”decision-making process for a 510(k) submission.
  2. To examine the 510(k) submission processes as a whole.
  3. To prepare a traditional 510(k) (a write-up of key sections of a submission) in a team project.

Subjects Covered:

  • Predicate device
  • Substantial equivalence
  • 510(k) submission process
  • ISO 21535 Non-Active Surgical Implants—Joint replacement implants
  • ISO 10993 Standards for evaluation biocompatibility
  • ISO 7206-5 Standards for mechanical and fatigue testing-implants for surgery
  • ASTM F1875-98(2009) Standard Practice for Fretting Corrosion Testing of Modular Implant
  • Interfaces
  • Code of Federal Regulations, Title 21, Parts Covered:
    • 21 CFR Part 807.92(a)(3) Legally marketed device
    • 21 CFR Part 807 Subpart E Premarket Notification
    • 21 CFR Part 812 Investigational Device Exemption
    • 21 CFR Part 56 Institutional Review Board
    • 21 CFR Part 50 Protection of Human Subjects
    • 21 CFR Part 54 Financial Disclosure
    • 21 CFR Part 814.3 Premarket Approval of Medical Devices

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5) Regulatory Pathways for Pediatric Medical Devices: Marketing a Pediatric Medical Device via a Humanitarian Device Exemption

DOCUMENTS:

DESCRIPTION:

A start-up company investigates marketing pathways for a unique pediatric medical device. This fictionalized case study explores the process of obtaining Humanitarian Use Device Designation and Humanitarian Device Exemption Approval for a pediatric cardiac device.

Learning Objective(s):

  1. To examine the challenges and opportunities for marketing pediatric medical devices
  2. To understand Premarket Assessment of pediatric device applications
  3. To explore regulatory pathways for pediatric medical devices

Subjects Covered:

  • Humanitarian Use Device Designation (HUD)
  • Humanitarian Device Exemption (HDE)
  • Code of Federal Regulations, Title 21, Parts:
    • 21 CFR Part 814.104, HUD and HDE
    • 21 CFR Part 814.3(n), Population Estimate for the HUD population
    • 21 CFR Part 58, Good Laboratory Practice (GLP) for nonclinical laboratory studies
    • 21 CFR Part 812, Investigational Device Exemptions
    • 21 CFR 820, Quality System Regulation

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6) Using the De Novo Process to Classify and Bring to Market an Innovative, Low-to-Moderate Risk Device 

DOCUMENTS:

DESCRIPTION:

A start-up company investigates marketing pathways for a device-based treatment approach that could improve the quality of life of patients living with Parkinson’s disease (PD). This fictionalized case study explores how to use the de novo process to classify and bring to market an innovative, low-to-moderate risk neurological device to aid in the treatment of PD. 

Learning Objective(s):

  1. To introduce the concept of the de novo process for classifying and receiving marketing authorization for a novel, low-to-moderate risk medical device.
  2. To understand what types of novel medical devices may be suitable for the de novo process.
  3. To examine the concept of substantial equivalence [as part of the 510(k) process] and how it relates to a device’s suitability for the de novo process.
  4. To explore the steps for requesting classification of a novel medical device into Class I or Class II via the de novo process.
  5. To apply the concepts of the de novo process to an innovative low-to-moderate risk PD treatment device. 

Subjects Covered: 

  • Regulatory background of the de novo process
  • Medical device classification; product codes
  • Intended use;
  • Premarket notification; Substantial Equivalence (SE); predicate devices
  • 513(g) submissions; Q-subs  
  • Medical device database 

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7) Seeking early feedback from FDA through the pre-submission program

DOCUMENTS:

DESCRIPTION:

A start-up company investigates regulatory requirements for marketing their in-vitro diagnostic (IVD) device for improving the detection and monitoring of myeloma, by early engagement with FDA. This fictionalized case study explores how to use the pre-submission program to engage with the FDA early in your product development process.

Learning Objective(s)

  1. To understand how to use the Q-Sub program to seek FDA feedback on specific topics.
  2. To identify when a Q-Sub would be useful for applicants and study sponsors.
  3. To review the unique process applicable to a Pre-Sub, using a fictional IVD device.
  4. To review to the general considerations for conducting nonclinical studies on an IVD, using a fictional IVD device.
  5. To prepare a partial Pre-Sub request in a team project.

Subjects Covered:

  • Background of the Q-Submission program
  • Medical device classification; product codes
  • IVDs; Nonclinical Study Design
  • Intended use; Premarket notification; Substantial Equivalence; predicate devices
  • Medical device database

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8) The Investigational Device Exemption (IDE) Process: When is an IDE the right choice?

DOCUMENTS:

DESCRIPTION:

A medical device manufacturer investigates regulatory requirements for marketing their high-risk deep brain stimulation device to treat Parkinson’s disease. This fictionalized case study explores how to use the Investigational Device Exemption (IDE) Process to introduce a high-risk device into the market.

Learning Objective(s)
  1. Explain what an IDE study is and what types of medical devices do and don’t need an IDE study.
  2. Understand the difference between a significant risk (SR) device and a non-significant risk (NSR) device.
  3. Understand the IDE approval process, the various possible FDA decisions on an IDE submission and how sponsors generally respond to those decisions.
  4. Learn how to develop a clinical investigational plan for an IDE application.
Subjects Covered
  • Investigational device exemptions (IDEs)
  • Significant risk devices; Non-significant risk devices
  • Designing IDE clinical study
  • The IDE approval process
  • Medical device database
  • Medical device classification;
  • Intended use

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Page Last Updated: 01/11/2016
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