Acceptance and clearance from FDA is the gold standard for medical devices, no matter what country they’ll eventually be marketed in. Even if the device is not released in the United States, FDA clearance provides “street cred” and marketing mojo for products from foreign countries because of the high value manufacturers and patients place on the blessing of our primary regulatory agency.
It can be a challenging journey. Here’s what you need to know before you hit the road.
Parts is Parts:
Every medical device is somehow unique, so there really is no standard assembly line or single starting point. But there are common features and parameters that apply to just about any device to help you minimize road hazards and other obstacles to give you reproducible, successful results.
How long will it take to get to market? Does the market currently exist? How big is the market? How long will it take to make a return on my investment? Is it reimburseable? Do I have the resources to make it all the way to market? Based on the regulatory path, what is the timeline to get to market? What are the costs of development? And that’s just to get you started thinking about all the other questions you should ask.
Don’t Kid Yourself:
If you don’t know, find someone who can help you. A reliable, knowledgeable navigator will make all the difference in how well and quickly you travel the road to market.
Know Your Make and Model:
In the United States, there are three classes of medical devices: Class I, Class II and Class III. There are significant differences in requirements and time to clearance or approval. Once you know which class your product falls into, you’ll have a much clearer idea of how to proceed.
Know the Rules of the Road:
Because the FDA is an evolving organization, the landscape will change with each submission. New clinical data, medical device reporting and new ASTM standards lay the path for future submissions. Just because you included something in a previous submission, that doesn’t mean the same rules still apply.
Know your plot lines:
The road to regulatory approval is really the chance to write your own story for your medical device. Although there is no standard form for submissions, there is a right and wrong way to submit your information. If your submission is well-written and easy to follow, it’s the foundation for productive, positive dialog with your reviewer, who’s a new reader. The more in-depth, clear and vetted information you can provide, the quicker you can travel the road to market.
Who’s Driving This Thing Anyway?
You know what kind of device you have, what kind of market you’re tackling, what you need to do to get it approved, how it’s getting reimbursed, and when your shareholders (or you) can expect to make money. Now you need to know who’s behind the wheel. You need and deserve the very best partners to make this road trip as easy and successful as possible. Empirical is here to join and support your team to ensure your journey to market is as smooth, fast and enjoyable as possible.
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