FDA Lawyer, More Than Just Food & Drugs
>> 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.
Medical Devices
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.
Product Development
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.
Cosmetics
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.
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