United States Medical Device Registration Chapter 7 – Device Listing



it's been a long road but there's light at the end of the tunnel the last steps in the process of bringing your device to market in the u.s. include listing your device registering your establishment and paying the associated fees listing your device and registering your company as well as those associated with manufacturing your device comprised of the last legs in the process establishments also known as companies register devices get listed there is a distinction any firm involved in any facet of the production or distribution of a medical device for commercial sale in the US must register annually with the fda fda establishment registration is important in order to enable the fda to protect public health and to respond to public health emergencies establishment registration requires you to list all devices as well as all activities related to those devices at your firm importers or distributors taking first title to imported devices must also register with the FDA registration and annual renewal fees vary and prices change from time to time for a complete pricing schedule visit FDA's website once the fda has cleared your device for marketing in the US the agency will issue you a 510 K clearance letter and post your 510 case summary on its website you will not however receive a registration certificate congratulations now you are authorized to sell your product in the US the hard part is over keep in mind there are fees associated with maintaining your registration that brings us to the end of this module and this series on bringing your medical device to market in the US in it we covered how the US is one of the most active markets in the world the Food and Drug Administration is the governing regulatory body and there are approximately six steps involved in the entire process depending on your type of device speaking of which we learn how you can use the FDA tool to determine your device classification and the differences between those classifications we also took a look at the FDA quality system regulation 21 CFR part 820 product testing is a requirement for a higher-risk products and there's plenty of documentation to assist you with those processes we look at the different types of 5 10 KS and documents that must be submitted we also learned that if you company is outside of the US you're required to obtain an in-country representative last we discuss the final steps including device listing and establishment registration we hope you've enjoyed this video series and learn some valuable information this is just the tip of the iceberg though a wealth of resources are available on our website WWE group com forward slash USA bye for now

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