US FDA Registration in India
CIL provides US FDA Registration Services in India & abroad. Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration. In order to be able to sell a product in the United States, you need to register with the US Food and Drug Administration for US FDA Registration. This is a process that involves submitting an application and paying a fee. Every company that makes a product for sale in the USA is required by law to register with the FDA. The Public Health Security and Bioterrorism Preparedness and Response Act of2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food, related emergencies. US FDA Agent, All foreign Establishments must identify a US FDA Agent while in the registration process. This is a mandatory requirement, and without US FDA Agent, the registration cannot be completed. Liberty Management Group Ltd provides US FDA Agent service to foreign food, drug, API, and medical device establishments. Why Should You Hire US FDA Agent. The US FDA Agent is a professional service company who helps ensure that the products and processes used in manufacturing are safe and the establishment is registered and products listed. The US FDA Agent inspects facilities, reviews production processes, and conducts GMP audits if required as per FSVP. They also conduct training sessions for staff members to ensure that everyone working at these facilities is following proper safety and health protocols. With the help of experienced US FDA Agent and FDA consultants, you do not have to worry about regulatory compliance. You can focus on getting your product to market and making a name for yourself in the industry. Well take care of everything else related to US FDA Registration. Appointing us as a FDA agent can avoid your conflicts when you work with multiple distributors, Importers, and agents. We assure permanent US FDA compliance with regulations over the period, no matter your relationship with distributors and importers in the USA. Why is US FDA registration required Manufacturer of Food, Drug, and Medical device requires US FDA registration for their facilities. US FDA Registration is only needed if you are planning to market your products in the USA. The US FDA medical device & IVD approval process. Step 1 Determine the classification of your medical device or in vitro diagnostic (IVD) device by searching the FDA classification database using relevant search terms, or by identifying another (predicate)device with the same intended use and technology. Pay special attention to the three, letter Product Code and seven, digit Regulation Number associated with the predicate devices you identify. If the classification cannot be determined, use the 513(g) process to request classification from the FDA. Step 2 Some Class I devices are exempt from most QSR requirements, with exceptions. For Class II and III devices, implement Quality Management System (QMS) that meets the FDA Quality System Regulation (QSR) found in 21 CFR Part 820. Step 3 Innovative Class II and all Class III devices will likely require clinical studies. Get Pre, Submission (Pre, Sub) feedback from the FDA. Step 4 If clinical studies will be required, apply for an Investigational Device Exemption (IDE). Develop clinical trial protocol and conduct study. Non, significant risk studies may be performed with IRB approval. Step5 For Class II devices, prepare and submit 510(k) Premarket Notification application and pay related fee. For Class III devices, prepare and submit Premarket Approval (PMA)application. Pay PMA submission fee. Step6, For Class III devices, FDA conducts facility inspections of manufacturer and all major suppliers involved in the design and production of your device. All parties must be compliant with FDA QSR. Step 7, For Class II devices, the FDA issues 510(k)clearance letter and posts it online. For Class III devices, the FDA issues PMA approval letter and posts it online. Step 8, At this time, you must be in full compliance with QS Rs. The FDA will not inspect Class I or II device manufacturers for compliance prior to device registration, but once registered, the FDA may conduct random inspections and can issue a Form 483 for non, compliance. Step 9, If you have no local presence in the US, appoint an FDA US Agent representative as a local point of contact with the FDA. Step 10, List your device and register your company using FURLS system on the FDA website; pay fees for Establishment Registration and Listing, which must be renewed each year. Step 11, You are now able to sell your device in the US. Your company and device registration status will be listed on the FDA website. Your authorization does not expire as long as no changes are made to the device design, intended use, etc.
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