The U.S. FDA regulates medical device products intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease intended to affect the structure or any function of the body of humans or other animals. Registrar Corp provides Registration, U.S. Agent, and Regulatory Compliance Assistance for U.S. and Non-U.S. Companies in the Medical Device Industry.
Owners or operators of places of business that are involved in the production and distribution of medical devices intended for use in the United States are required to register with the U.S. FDA annually. Firms involved in manufacturing, packaging, labeling or reprocessing of devices must pay an annual fee. Many establishments that are required to register with the U.S. FDA also are required to list their devices. For assistance with U.S. FDA medical device registration and listing regulations, simply click the Medical Device Certificate of Registration shown on the left.
In addition to establishment registration and medical device listings, certain medical devices require 510(k) clearance by the U.S. FDA before they may be sold in the United States. To obtain 510(k) clearance, companies must file an application with scientific and technical information sufficient to demonstrate that the device is substantially equivalent to a device already legally marketed in the United States. For assistance with U.S. FDA 510(k) submissions, simply click the 510(k) Certificate of Registration shown on the left.
A Medical Device Master File is a submission to U.S. FDA that may be used in support of premarket submissions to provide confidential detailed information about establishments, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more medical devices. Registrar Corp's team of medical device regulatory experts provides guidance as to required elements, formats, and particularities of Medical Device Master File submissions. For assistance submitting a Medical Device Master File, simply click the Medical Device Master File Certificate shown on the left.
Labeling mistakes result in more than 22% of all detentions in the United States. Registrar Corp helps companies modify medical device labeling to comply with U.S. FDA regulations. Registrar Corp provides revised graphic files ready to be printed or edited, and a report that details the regulations, compliance guides, warning letters, import alerts, and other guidance documents from the U.S. FDA. To learn how U.S. FDA medical device labeling regulations apply to your products, simply click the FDA Notice of Action shown on the left.
A medical device color additive is any dye, pigment, or other substance that can impart color to a medical device. Medical device color additives are regulated by the U.S. FDA. To determine how U.S. FDA's medical device color additive regulations apply to your medical devices, simply click the Notice of FDA Action shown on the left.
Companies registered with U.S. FDA often are asked by their customers and suppliers to verify their U.S. FDA registrations. A Certificate of Registration issued by Registrar Corp serves as a third-party verification of your U.S. FDA registration. For more information, click the Medical Device Certificate of Registration shown on the left.
U.S. FDA Regulations:
U.S. FDA Medical Device Regulation: 21 C.F.R. Part 801 et seq.
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
U.S. FDA MAF Regulation: 21 C.F.R. section 814.9.
U.S. FDA Medical Device Labeling: 21 C.F.R. sections 801.1 et seq.
U.S. FDA Color Additives: 21 C.F.R. Parts 73, 74, and 80
Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
