>> Nov 8, 2012
Did you know that FDA regulations cover more than just food and drugs? In fact, the FDA is responsible for making sure that food, prescription and over the counter drugs, dietary supplements, cosmetics, and medical devices. Whether your company manufactures and packages snack foods or lipsticks, you will still have to fill out forms to send to the FDA, and comply with all of their rules and regulations. Because of this, hiring a lawyer for your company is often a very good idea even if you don't deal directly with food or drugs.
All companies dealing with medical devices, even distributors must have a reliable system in place for tracing purposes and ensuring that every step of product development is in compliance with FDA regulations. Although many medical device facilities might be ISO certified, the FDA regulations usually need some other documents to be included in your paperwork. An FDA lawyer can ensure that your company has filed all the appropriate paperwork in a timely manner.
When working with medical devices, product development involves a little more than coming up with a concept and creating it. The FDA will need to know what the product is claimed to do, and many different forms will be required before you can begin to sell the product. An FDA lawyer will help you with every aspect of product development. Some of the things that your lawyer can help you with are: advertising requirements, medical claims, third party reviews, promoting the device, and coordinating with FDA investigators. An FDA lawyer will be able to determine whether a new medical device will require any pre-market notifications to be filed with the FDA, and what forms will be needed for registrations and device listings. If a pre-market notification, otherwise known as a 510(K) application, needs to be filed, your lawyer can make sure that all the necessary paperwork is collected and filed along with the application.
All cosmetics that are marketed in the U.S.A. have to comply with regulations from the Federal food, Drug and Cosmetic Act, the Fair Packaging and Labeling Act and many other federal rules and regulations. These rules are all in place to ensure that cosmetics and their packaging are free from poisons, and contaminants. The FD&C Act also ensures that the cosmetics are packaged correctly, the labels do not contain false information or are misleading, and that the label includes all legally required information.
If you plan to manufacture, package, or distribute medical devices or cosmetics, you will still benefit from having an FDA Lawyer available to help ensure that you file all the necessary paperwork and comply with all of the many rules and regulations. Your FDA lawyer will work with you through every step of the process, from filing the forms to ensuring that the package labels are accurate prior to shipping your merchandise to retail locations. They can also run regular internal audits to ensure that you are ready for any FDA inspection that may occur.
Trish Rounsaville is a freelance writer based in the U.S. who enjoys writing blogs about the legal system. She has a particular interest in the wide scope of the FDA and the need for many companies to find a reputable FDA Lawyer Arrastia-Law.