In the medical device industry, there is a longstanding divide between device manufacturers and the third-party entities that service the devices. The parties that manufacture the devices are subject to substantially more regulation by the FDA than the parties that service the devices. The FDA has recently focused its efforts on providing clearer guidelines differentiating the two activities. This webinar will explore how the FDA defines the industry players, the FDA’s recent actions regarding device servicing and manufacturing, the substance and conclusions of recent FDA publications on the topic, and what these actions and publications mean for the industry.
Who Should Attend
Pharmaceutical and medical device attorneys
Product liability attorneys
FDA regulatory compliance attorneys
What You Will Learn
How the FDA currently defines device manufacturers and the third-party entities that service the devices, and how industry players should discern which type of entity they are for purposes of determining the FDA regulation(s) that will apply as a result.
What recent FDA publications on servicing and manufacturing tell us about future steps the FDA may take regarding medical device servicing and manufacturing.
Important trends and future effects for the industry and steps industry players should consider as the FDA's involvement in this area continues to develop.