The Food and Drug Administration (USFDA) is a federal agency of the United States Department of Health and Human Services. FDA registration is the basic requirement for domestic and foreign organisation who wants to manufacture or Sale Medical device , PPE`s ,Food and Drugs in the USA. We will help you to get FDA registration, provide guidance with FDA requirements for your industry Specific.
Companies who are involved in manufacturing, testing, packing, labelling, sterilization or import of medical devices are required to register their facility and list their devices with the FDA. . AMSPL offers FDA medical device registration and listing services. we can provide expert advice on all regulatory requirements for medical devices. Our complete solution will give you the support you need until you have met all the FDA medical device regulations.
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective. Rare Class I and most Class II devices require a 510(k).The organisation 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).
The requirement of The U.S. Food and Drug Administration (FDA) that your device’s label to include adequate instructions for use, servicing instructions, warnings instructions, or information that may be necessary for the safe use . We will help you for your device’s labelling for compliance with FDA regulations.