Russell K. Statman, Esq., is a founder and Executive Director of FDA Registrar Corp., a firm providing registration, compliance assistance and U.S. Agent Services for the food and beverage, cosmetics and medical device industries. Mr. Statman is an attorney-at-law representing firms in FDA-regulated industries for the past eighteen years. Contact the author at: statman@fdaregistrar.com
Medical technology companies are making medical tools that help in improving health of millions of people across the globe. With a plethora of medical industries striving to make a name for themselves in this competitive marketplace, the U.S. Food and Drugs Administration (FDA) is placing a great importance to the adherence of health care standards. Medical drugs and medical devices cannot be marketed in the United States unless the FDA grants specific approval. Thus, it is becoming important for companies to implement stringent medical equipment requirements.
All medical device manufacturing companies are required by the Food and Drug Administration (FDA) to meet governed specifications while designing, manufacturing, packaging, labeling, storing, and shipping medical instruments intended for human use. Their purpose is to ensure that these medical equipments and devices will be safe, effective and in accordance with the Federal Food, Drug, and Cosmetic Act as appropriate. But sometimes it is not possible to know the effects of certain medical devices unless they are used by the consumers.
For this purpose, MedWatch, FDA's adverse event and safety information reporting program plays an important role. It provides surveillance of medical tools, medical appliances and medical equipments post their release in the market. Through this voluntary program, health professionals report the problems with these medical equipments and help FDA regulate these products.
FDA Registrar Corp helps companies to comply with U.S. FDA Medical Device Establishment Registration and U.S. FDA Medical Device Listings. It offers help in getting required FDA registration for all U.S. and Non-U.S. companies that engage in the manufacture, preparation, propagation, compounding, assembly or processing of any medical equipment. So, companies can avoid any civil or criminal liability by availing the expert services of FDA Registrar Corp.
It's quick and easy!
FDA Registrar Corp makes registering your Medical Device Establishment with the U.S. FDA quick and easy. The three-step procedure is designed to make the whole task convenient and less burdensome for you. Often, it becomes difficult to comprehend the rules and regulations that are required by law in case of medical appliance. So, FDA Registrar Corp makes it convenient for companies especially non-U.S. companies to overcome the hurdles of complex paperwork and manifold formalities and work smoothly and legally. Moreover, it's always beneficial to follow the set rules and framework so as to avoid any penalties and work in a conducive environment.
Also, the U.S. FDA has strict regulations concerning the labeling of medical equipment whose aberrations results in more than 22% of all medical device detentions in the U.S. Avoid detentions by having your Medical Device labels reviewed by FDA Registrar Corp prior to sale in the USA. Besides providing Registration, U.S. Agent services, Compliance Assistance for U.S. And Non-U.S. Companies, FDA Registrar Corp also offers the gamut of these facilities to Food & Beverages Industries and Cosmetic Industries.
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Just want to know if your company assists non-US Drug Manufacturers (Contract Manufacturers)to be their US FDA Agents? Special concern for us would be updates according to the new electronic system of Drug Establishment Licences and Drug Product Listings.
Thanks in advance.
Gudrun
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