Classifying Medical Devices as per FDA Regulations
Instructor : Charles H. Paul
Oct 26, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes
Steps for Classifying a Medical Device Using the FDA Product Classification Database
The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The determination process, how you apply the process to your device, is complex and requires several levels of analysis to make the proper device classification. When designing and developing medical devices it is essential to properly classify your device early on in the process to prevent costly and cumbersome regulatory issues and added or unnecessary work later in the design and development process.
This webinar by leading consultant Charles H. Paul will provide insight into the classification process regulated by the FDA and will provide a methodology to assist in properly making your classifications. It will cover the steps for classifying a medical device using the FDA Product Classification Database. Key definitions related to classifying medical devices will be provided to include intended use, indications for use, risk and general and special controls. Charles will also cover the EU medical device classification process and compare it to the US process.
At the completion of this webinar, you will be able to effectively classify a medical device in both the US and the EU. For a US classification, participants will be instructed step-by-step in how to use the FDA’s classification database to make a classification determination. For the EU, this webinar will guide participants through the complex process of applying the classification rules to determine the appropriate EU medical device classification.
- Medical Device Definitions
- US Medical Device Classifications
- EU Medical Device Classifications
- Key Terms and Definitions
- Explain General and Special Controls and how they are applied
- Types of Medical Devices
- How US Medical Devices are classified
- How EU Medical Devices are classified
- List and describe the applicable US and EU regulations for Medical Device classification
Who should attend
This webinar is applicable to the Medical Device industry especially staff members involved in the classification of medical devices either in the US or the EU. Position titles that this webinar will benefit include Associates, Managers, Directors, and Vice Presidents. The following positions are more descriptive of those applicable positions:
- Audit and Compliance Personnel / Risk Managers
- Research and Development Engineers
- Vice-Presidents, Directors, and Managers of Medical Device Design Functions
- Medical Device Marketing Personnel