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 the 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.
Frequently asked questions
Is this FDA training specific to a domain? (i.e. Medical Device, Biotech, Pharma etc)
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.
Will this course allow for submission my medical device FDA submission?
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.
How much material will be provided with the FDA Online Course?
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.
What are the core offerings of the program?
The program can be broken out into the following categories: