| Start Date: | 3/6/2015 | Start Time: | 4:00 PM |
| End Date: | 3/6/2015 | End Time: | 5:30 PM |
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Event Description
Sonna Patel-Raman, PhD, Consultant II at the Halloran Consulting Group, Inc. in Boston, MA, will discuss how many companies face the following two scenarios when they wish to market their device: Scenario One: You have spent the last 3 years developing a new medical device to treat stenotic eustachitis. Your device design is finalized and you have completed all of your bench testing and animal studies. You were able to leverage existing literature on a similar device and you believe your device is Class II. Fortunately, you do not need any clinical data. What does it take to get clearance from the FDA?
Scenario Two: You recently finished your first-in-human study of a Class III, gastroapical shunt closure device, also a novel therapy. This device requires a large clinical trial to demonstrate safety and effectiveness because of the patient risk and life-sustaining nature of the device. What are the requirements to achieve approval for a Class III medical device?
The United States Food and Drug Administration (FDA), regulator of medical devices, and industry organizations have long engaged in a love-hate relationship because both sides believe in their mission: FDA wants to promote and protect the public health, while industry strives to rapidly market a therapy that is safe and effective. FDA's dual mission of protection and promotion can only be achieved through appropriate regulation of innovation and permission to allow patients access to novel therapies in the United States. To some, this is perceived as a barrier; to others, there is not enough regulation.With a past that is on record for being overly conservative and lengthy, and riddled with inconsisent feedback, many seasoned veterans of device development believe that FDA is not, and cannot, be forward thinking. Fortunately for industry, that typically conservative paradigm is changing. With extensive internal training and industry education, the benefit to risk paradigm is being more frequently applied to marketing applications with greater focus on benefits instead of risks.
This seminar will discuss FDA market approval/clearance pathways for medical devices and how devices are reviewed for approval and clearance in the United States. In addition, this presentation will highlight some industry secrets for maximizing FDA interactions. For more info, please visit www.biomed.drexel.edu. |
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Location:
Papadakis Integrated Sciences Building (PISB), Room 120, located at the corner of 33rd and Chestnut Streets. |
Audience:
Undergraduate StudentsGraduate StudentsFacultyStaff |
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