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In this situation, a 510K would be required. Among other times, it's required "
For more information, please look here: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/#whennot
Please let me know if you need anything additional. If not, please rate positive.
I understand this Megan, however that is not true in every situation. what about predicate devices that already exist in the market in regards ***** ***** endoscope and reusable camera?
You will still need to fill out the disclosure indicating that the device is safe.
Hi, my name is ***** ***** I am happy to assist you. I have dealt with many companies getting their devices classified and through the pre market process. Your devices could be classified as a Class I which will not need to have a 501K. I have a personal contact with the FDA classification department and here is the email that you should send your request to listing your exact device and they will reach out most likely tomorrow since it is past 5 pm est.***@******.***. Please note that I am not your previous expert and please let me know if you would like me to assist you with getting pre market approval or classification of the devices. Thank you Hope