If you are launching a new food product, drug, or medical device, you are required to fill out a United States Food and Drug Administration, or FDA, registration and be approved. If you are launching a beauty product, registration is voluntary but recommended. If you have never filled out an FDA registration before, you may be considering working with an FDA attorney. As you think about the process, you may find yourself with many questions. Getting answers to the questions you have will help you to better understand the process and how an FDA attorney can be beneficial to you. Here are a few frequently asked questions you may have about FDA registration and an FDA attorney.
Do You Need to Use an Attorney When Filing an FDA Registration?
No, you are not required to use an attorney to fill out and complete the FDA registration process. You are able to complete the process on your own, if you so choose. However, there are many benefits to using an attorney, especially if you have never gone through the process before.
What Are the Benefits to Using an FDA Attorney for an FDA Registration?
There are many different benefits to using an FDA attorney to complete the FDA registration process when you are launching a new product that requires it. One of the biggest benefits is that an attorney with experience in this field knows what information needs to be submitted. Depending on the type of product, you may need to have a facility registration for both your company and any other companies that have manufactured or produced food or drugs that you intend to use or sell as part of your product line. In other instances, particularly when it comes to drugs, the drugs themselves must undergo the registration process as well as the facility that they are being manufactured in. An attorney knows what information you need to have based on the type of product you are manufacturing and selling. This can help you get your product approved faster and get you on your way to making a profit.
The other benefit to using an FDA attorney to complete the registration process is that you'll know everything is properly handled and taken care of. When you attempt to file on your own, you may not include all of your facilities, products, or manufacturing information, due to a simple mistake or oversight or because you didn't know the rules. Unfortunately, failing to provide or renew this information can lead to your registration being canceled or a civil or criminal action being brought against you in federal court due to your failure to abide by the strict laws set forth by the Food and Drug Administration. Using an attorney ensures everything is done properly so you don't face these issues.
What Should One Look for When Hiring an FDA Attorney?
If you have never worked with an FDA attorney before, you may be unsure what you should look for when hiring one. One of the factors to consider is what field the attorney specializes in. The FDA registration process is different for food, drug, and beauty products. Because of this, many attorneys specialize in just one of these fields. Finding an attorney who is experienced in the field you are looking for can be invaluable. Additionally, ask how many years of experience the attorney has in their field. That can help ensure they have the knowledge to properly file your registration forms in that industry. Lastly, ask the attorney what their submit-to-rejection rate is. If an attorney has a high rejection rate, they are making errors or failing to include information. This can prolong the process of being approved, so try to find an attorney with a low rejection rate.
Any time you are manufacturing a food product, medical device, or drug, you will need to register with the Food and Drug Administration. This is to ensure that Americans aren't subject to dangerous food or drugs and that the facilities these items in are clean and follow FDA laws. Going through this process can be intimidating. But you don't have to go through it alone. An FDA attorney can help you file the necessary paperwork, getting you the registration you need to begin making and selling your product.
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