In recent years, FDA has rolled out two new programs that are designed to expedite the go-to-market process for innovative medical devices:
Breakthrough Device Designation (BDD)
Safer Technologies Program (STeP)
Both programs offer exciting opportunities for medical device companies, but the application processes for obtaining designation for each contain plenty of nuance.
Isabella Schmitt, Director of Regulatory Affairs at Proxima, is here to help webinar participants demystify BDD and STeP by explaining the application processes and why getting these designations early in the regulatory process can help clear your device’s pathway to approval.
Isabella will help you crack the code using the same methods used with successfully counseling multiple companies through BDD and STeP designation processes, and help you learn what it takes to achieve BDD or STeP designation for your medical device.
A breakdown of the criteria for each program
How to create a successful BDD packet (spoiler alert: it’s not as easy you think)
How much information to include in applications – finding the balance between enough, but not too much
Explanation of what “more effective” and “reasonable expectation of clinical and regulatory success” mean in the context of BDD and STeP
Types of interactions you should expect to have with each program and how to navigate key relationships successfully
Medtech leaders and company founders
Regulatory affairs professionals
Medical device and diagnostic innovators
Medical device professionals interested in learning more about BDD and STeP applications
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You have an innovative medical device or drug, and you need an organization experienced in getting products approved and on the market. We know your needs. We know the pitfalls of the submission process and how to avoid them. From regulatory consulting to clinical research, Proxima is the dedicated full-service Contract Research Organization for emerging companies. Visit their website to learn more.