FDA Registration for New Drug is mandatory if you want to sell OTC and over the counter drug products in USA. Let’s take a look at how companies can navigate through the FDA registration method for safe distribution of their new pharmaceutical drugs.
In the United States, any individual or entity that manufactures a drug for commercial distribution needs to obtain prior approval from the Food and Drug Administration (FDA) before distributing the drug. Filing for FDA pre-market approval for a new drug product can be challenging, and should be done only with the assistance of a qualified regulatory affairs consulting firm with experience in drug product registration and approval.
The Food and Drug Administration (FDA) is the government agency responsible for ensuring that drugs, medical devices, biologic products, blood supplies, and cosmetics intended for human use are safe, effective and meet acceptable standards of quality. The Food and Drug Administration (FDA) regulates drug labeling to ensure that the labeling information on both prescription and non-prescription drug products is truthful and not misleading.
Any pharmaceutical product that is labeled ‘For Sale’ in the United States must be FDA-approved. With an estimated 9,000-10,000 drug products undergoing clinical trials at any given time, it’s impossible for the FDA to regulate all these products. To improve efficiency in the approval process, the FDA has created a formal procedure for drug manufacturers to follow before they can bring their new products to market…
Benefits of FDA Registration
Registering with the FDA can help you protect your brand and meet consumers’ expectations of quality. It also gives you access to information on how to sell food products internationally, including requirements for labeling and shipping.
- ~ Legitimize your company as an official business
- ~ Gain access to the FDA database
- ~ Gain credibility in the eyes of your customers
- ~ Ensure the safety and quality of your products
- ~ Make selling your products easier!
FDA Registration Process for Medical Devices
The FDA registration process for medical devices is a critical step in the development and marketing of any medical device. It allows you to market your product in the United States, but it also allows you to sell your device internationally and even receive reimbursement from Medicare or private insurance companies. Your registration number must be on each device you sell or distribute in the U.S., as well as on all product labels.
In order to register your device with the FDA, you must submit an application for premarket approval (PMA), which is a lengthy and complicated process that requires a significant amount of research and documentation. Once you have completed this process and received approval, you will need to pay an annual fee to maintain your registration as well as file annual reports.
In order to register your medical device with the FDA, you must submit an application for premarket approval (PMA). This application must include:
- ~ Classify Your Device
- ~ Determine Your Device’s Development Process
- ~ Create the Design History File
- ~ Complete the 510(k) Submission (for Most Pre-Market Approval Device Types)
- ~ Go Through Pre-Market Approval (for Most High-Risk Device Types)
FDA registration process is complicated and having detailed information about it can go a long way to help you do it more efficiently with less mistakes. For smoother process you should hire experts only.
I3CGLOBAL is your one-stop shop for registering your facility and listing goods in the United States, with over twenty-two years of expertise in US FDA Registration. We’ll assist you in navigating the FDA’s complicated regulatory standards to ensure that your products are given a fair shake. We’re dedicated to providing you with exceptional customer service, and we have the reviews to prove it.