Prior to exporting a Medical device in US it must be registered with US FDA .The device must be first correctly classified for choosing its regulatory path. The categories remain the same (class I, II & III) but classification criteria of US slightly differ from that of EU. Whether a device is 510 k exempt or not depends upon the classification of the device.Most of the class I and few class II devices are 510 K exempt, while some class II device required 510 K(PMN) approval. Class III devices required PMA in order to be placed in US.
Devices Registration of 510 K exempt Products
Devices which are 510k exempt needs to be registered and listed with FDA. Before registration the annual registration fees has to be paid.
Manufacturer not residing in US needs to appoint a US Agent in order to register his devices with FDA.
After registering the devices with FDA the facility is subjected to random FDA audit so it is necessary that your products comply with all the regulations as applicable to it.
Devices Registration of 510 K Products
For devices which are not 510 k exempt it is required to obtain a 510 k clearance for the device and then only the product can be listed on the FDA site.
There are two individual fees for each 510 k approval and product registration & listing. Both fees are revised each FY and the Fee information is updated on FDA site.
Small business can apply for a reduced 510 K review fee but there is no reduction in registration & listing fees.
Med devices has many years of experience in Product registration & successful 510 K submissions. We can help you in getting your product 510 K approved and registered; we also provide US Agent service, technical dossier preparation guidance and FDA audit compliance services.
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment.
Information about a foreign establishment’s U.S. agent is submitted electronically to FDA and is part of the establishment registration process. Each foreign establishment may designate only one U.S. agent.