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Medical Device

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Services: Medical Device

FDA US Agent for Medical Device Registration Renewal Lowest fee guaranteed .

We offer FDA US Agent for medical device registration renewal process.  Currently, if you are planing   to replace your existing US Agent in the medical device registration , we can offer you complete support for updating US Agent information in your medical device registration without any additional fee. Why you should  choose our services for… Read More


Companies who are involved in manufacturing, testing, packing, labeling, sterilization or import of medical devices are required to register their facility, pay FDA registration fees, and list their devices with the FDA. FDAbasics offers FDA medical device registration and listing services at competitive fees... Read More


Some Class I and most Class II devices require a 510(k). In a 510(k), the sponsor must demonstrate that the new device is “substantially equivalent” to a predicate device in terms of intended use, technological characteristics, and performance testing, as needed.
We provide complete assistance for Pre-Market Notification 510(k), at highly competitive fees. Please contact us for more information.
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Most Class III devices require Pre-Market Approval, or PMA. The PMA is the most stringent type of pre-market submission. We provide complete assistance for Pre-Market Approval at highly competitive fees... Read More

HDE (Humanitarian Device Exemption)

Humanitarian Device Exemption – or HDE – provides a regulatory path for Class III devices that are intended to benefit patients with rare diseases or conditions. If you are looking for any further assistance for HDE, Pragmatic can help... Read More


An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study to collect safety and effectiveness data, which can be required for Pre-Market Approval applications or a Pre-Market Notification. We provide support for IDE... Read More


De Novo provides a way for a new device, without a valid predicate, to be classified into Class I or II if it meets certain criteria. Pragmatic can help you with the preparation of your De Novo submission... Read More

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