FDA Online Courses & Consulting
Those in the health sciences are uniquely involved in many aspects of medical device development, from the inception of the idea to its delivery in the marketplace. There is often a “black box” towards the end of this process where a device submission goes into the FDA and you hope an approval or clearance letter comes out the other side. Understanding the mechanisms of the FDA regulatory system governing the marketing and clinical use of medical devices in the United States can be enormously helpful not just at these later stages, but even during research and development of a new device! Being prepared regarding regulatory pathways and medical device classification will save huge amounts of time, money, and effort.
It is our goal to arm you with the FDA training you need to guide your device through the certification process and have a deep understanding of how the regulatory process is involved in every phase of medical device development.
- 14 Weeks Of FDA Training
- Over 40 Hours Of Learning Material
- $3100 / Person
IN-PERSON WEEKEND SEMINAR
- Two 8 Hours Days of Instruction
- Group Discounts Available
- Offered In Irvine Ca Or Columbia, Md Locations
- $3100 / Person
- Flexible Course Durations
- Offered Online and In-Person
- Rates Available on Request
Regulatory Pathways, The Q-Submission Program, & Using Standards to Fulfill Submission Requirements
Pre-Market Notification (510k) & De Novo Programs Using Orthopedic Case Studies
A complete overview of the medical device classification landscape and how the classifications relate to the available regulatory pathways. We will also discuss the Pre-Submission Program (formerly known as the Pre-IDE Program). The goal of this program is to obtain feedback from the FDA prior to formal FDA submissions. If you are wondering about the proper submission pathway because you are unclear on the classification of your device, this is the mechanism you would use.
The second half of material will highlight how consensus standards are useful, where they are derived from, who is responsible for creating and maintaining them, and how they are utilized by the biomedical device industry. There are many, many types of medical devices, which contrary to popular belief, are cleared for marketing in the United States without any level of clinical performance testing. In lieu of clinical performance testing, standardized testing and standardized test methods (sometimes with objective performance criteria) are used to approximate device similarity and "borrow" a proven clinical performance record. Our discussions of this topic will use examples of medical devices and medical device submissions to illustrate how standards come about and how the FDA uses them.
This explores an overview of the regulatory pathways for low and low-to-moderate risk (usually Class II) devices. We begin by describing the 510(k) pre-market notification program, then discuss the sections of a 510(k) submission, outline the 510(k) process, and discuss the types of decisions the FDA will render in response to a 510(k) submission. The discussion also explores the De Novo pathway and how it can be used for low to moderate risk devices for which suitable predicate devices cannot be found. Using orthopedic case studies, real-world examples will be shown which demonstrate how a 510(k) submission works and the decision points an FDA reviewer goes through when assessing a medical device for substantial equivalence. The utilization of the 510(k) flowchart will be demonstrated and the module will cover issues of intended use, technological characteristics, questions of safety and effectiveness, and lastly performance data.
Investigational Devices Exemption (IDE) & Early Feasibility Studies Using Neurological and Physical Medicine Case Studies
We will discuss Investigational Device Exemptions and Early Feasibility Studies. The FDA not only regulates what medical devices come to market but also the examination of these devices as they are going through clinical investigation and trial. In this topic we go through one case study which revolves around bringing a deep brain stimulation (DBS) technology from bench to market. The case focuses on what is needed for a device in this space for clinical studies to support an application for market to the FDA. We will then shift gears and spend some time talking about a recent guidance document issued by the FDA on clinical considerations for neurological devices specifically targeting disease progression, which is a bit different from DBS which targets symptom management. Changes in intended use such as this present a unique opportunity to evaluate the relationship between investigation of a device and marketing of a device.
Premarket Approval (PMA) & Humanitarian Device Exemption Programs Using Cardiovascular Case Studies
This topic explores Pre-market Approvals (PMAs) and Humanitarian Device Exemptions (HDEs). These are the marketing applications required for Class III medical devices. In this discussion, a high-level overview of the regulations will be examined, and the contents of premarket approval applications will be discussed. This content provides the basic information and knowledge needed for our next discussion where we will dive a bit deeper into premarket approval applications with a case study on coronary artery disease treatment. During this case study, we will explore specific non-clinical testing recommended by the FDA (including the “why” behind this testing), as well as some other recommendations that can be followed to ensure that the documentation provided in YOUR next PMA submission is adequate for acceptance and filing review.