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.
- Medical Devices
- Food and Agro products
- Other FDA-Regulated Products
1.MEDICAL DEVICE ESTABLISHMENT REGISTRATION AND DEVICE LISTING
Companies who are involved in manufacturing, testing, packing, labeling, 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.
Process: After receipt of the completed medical device registration form, we will create a GDUFA cover sheet for making the FDA fee payment. The GDUFA cover sheet will have the PIN number and wire transfer details of the FDA. Client has to pay FDA fee for medical device registration, After payment to the FDA, it will take about 5 to 6 business days for obtaining PCN (Payment Confirmation Number). Once the PCN is received, we will send you the draft medical device registration document for your review and approval, after your approval we will submit the registration to FDA. Upon successful, registration FDA will assign the operator number immediately. It will take approximately 60 business days to obtain the registration number from the FDA. However, you can start shipping the product once the operator number is assigned.
2.PRE MARKET NOTIFICATION 510 (K)
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).
3.Medical Device Labelling
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 instrutions, or information that may be necessary for the safe use . We will help you for your device’s labelling for compliance with FDA regulations.