All establishments that produce and market medical devices in the United States have to follow a registration process with the FDA called “Establishment registration” within 30 days of commercialization of the medical device.FDA Establishment Registration E&E Medicals and Consulting is a US FDA Agent with consultants supporting manufactures & distributors during the online FDA registration certificate and listing process. The Food and Drug Administration of United States (US FDA) protects the public health by ensuring the safety, efficacy, and security of Food Supply, Drugs and Biological(s), Medical Devices, Cosmetics, Radiation Equipment and Tobaccos through regulations that are related to the manufacturing, marketing, and distribution. Hence, business owners and operators (FDA ESTABLISHMENTS or FACILITIES) within the ranks for these industries must REGISTER their facilities with the US FDA. The US FDA Registration process varies dependent on the type of product to be marketed in the U.S.
FDA Medical Device Establishment Registration
FDA Registration of Medical Device Facility Business owners and operators of the medical device industry involved in the manufacture and distribution of medical devices intended for use in the United States are required to complete annual Registration of FDA. The CFR 807 section also requires that the FDA certificate of registration requires the listing of those devices. ONLY those devices exempted from PMA or 510k clearance could be directly registered with the FDA.
E & E Medicals will help you define your medical device establishment registration requirements and guide you through the electronic establishment registration and medical device listing process, which uses the FDA unified registration and listing systems (FURLS)
FDA Drug & Cosmetic Establishment Registration
E & E Medicals and Consulting provides the following services to pharmaceutical companies
- GMP Consultancy for Pharmaceuticals
- Pre-audit inspection
- Assist in responding to 483 letters
- Establishment registration
- Drug listing