Why Classify Your Medical Device for the FDA?

Posted by Lisa Capote | May 10, 2017 | 0 Comments

Classifying your medical device with the FDA can seem overwhelming. It's important to take things one step at a time. There are three major classifications for medical devices under FDA law. It's crucial to understand why you need to classify your medical device.

What Requirements Should You Be Meeting While Designing or Manufacturing Your Device?

Learning about medical device classification before you design or manufacture your device can help the FDA approval process go smoothly. You can eliminate bumps in the road by anticipating what you'll need. Therefore, have it ready as you design and manufacture your device.

What Requirements Should You Be Meeting Before Submitting Your Device?

One imperative part of classifying your device is to know what requirements you need to be meeting before you submit your device to the FDA. Some classifications of devices don't have as many requirements that must be met pre-market, while others have a great deal. You should be a step ahead of the game when it comes to knowing what you need to do before you can sell your medical device.

Know How Much It Will Cost to Get Your Device to Market

Another helpful benefit of understanding FDA classification for medical devices is that it can help you better estimate how much it's going to cost to design, manufacture, advertise, and sell your product. For most people, this is a crucial piece of information that will help them determine whether or not they can actually bring their medical device to market.

How to Get Help With Medical Device FDA Regulations

FDA regulations surrounding medical devices are confusing at best. It's always a good idea to consult with an experienced professional who knows FDA law from front to back and can give you the guidance you need to move through the various stages of designing and marketing a medical device.

Contact the Capote Law Firm today for a consultation to discuss the details about your medical device. Whether you're just beginning to have an idea of a medical device you can sell, you're in the middle of manufacturing your device, or you've made your device and need to submit it to the FDA, we can help.

Call us now at 786.871.5680. We are available now to give you the information you need to make informed decisions going forward.

About the Author

Lisa Capote

Ms. Capote is the founder and Managing Partner of Capote Law Firm. She founded the minority, woman owned law firm in 2006 with the goal to provide quality service to FDA regulated companies. Since that time her practice has grown to include other US federal agencies as well as an international trade component.


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