FDA在線課程

Yes! This guided instruction will help those in Medical Device and MedTech to understand how to navigate the submission process as well as critical items that come before and after.

(While this course does walk comapnies and entrepreneurs through the process, the instructor will not actually perform the submission process or be in contact withthe FDA)

The main focus of these courses will be on the regulatory pathways for medical devices only and will not focus on other types of therapies.

You can expect up to 40 hours of material related to FDA submissions and guidance around handling your product with the FDA. This is about the equivalent to one college level course worth of material. This material can be saved and referenced at at a later date as you navigate your product journey with the FDA.

The program can be broken out into the following categories:

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.

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.