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Home › U.S. FDA Medical Device Regulations

U.S. FDA Medical Device Regulations

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.

Medical Device Establishment Registration & Listings Medical Device Examples
Medical Device Certificates Issued By Registrar Corp
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.
   
Electronic Medical Device Reporting (eMDR)
Cert of GUDID Reporting
FDA now requires medical device manufacturers and importers to submit adverse event reports in electronic format. Device manufacturers and importers are required to submit adverse event reports to FDA when evidence suggests a device may have contributed to a patient death or serious injury, or when a device malfunctions and reoccurrence of the malfunction would likely contribute to death or serious injury. For assistance with submitting adverse event reports to FDA in eMDR format, simply click the link above.
   
Data Universal Numbering System (DUNS Number)
Data Universal Numbering System (DUNS Number)
Medical device establishments with devices subject to FDA UDI requirements must obtain a Data Universal Numbering System (DUNS) number. To obtain a DUNS number for your establishment free of charge, simply click the certificate on the left.
   
Unique Device Identifier (UDI) and Global Unique Device Identifier Database (GUDID) UDI Compliance Dates
Cert of GUDID Reporting
Most medical devices distributed in the U.S. are required to include a numeric or alphanumeric code as a unique device identifier (UDI). FDA also requires submission of device and UDI information to the Global Unique Device Identifier Database (GUDID). For assistance with UDI compliance dates and GUDID reporting, simply click on the link shown on the left.
   
510(k) Administrative Review & Submission  510(k) Device Examples
510(k) Medical Device Certificates Issued By Registrar Corp
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.
   
Medical Device Master Files (MAF)  Medical Device Master File Examples
Medical Device Master File Certificates Issued By Registrar Corp
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.
   
Medical Device Label Reviews and Graphic Design
Label Reviews and Graphic Design
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.
   
Medical Device Color Additives and Medical Device Color Batch Certification
Medical Device Color Additive Notice of FDA Action
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.
   
Certificate of Registration issued by Registrar Corp
Medical Device Certificates Issued By Registrar Corp
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.
   
Detention Without Physical Examination ("DWPE") Assistance
Detention Without Physical Examination Assistance
Companies shipping products to the United States may find their shipments subject to "Detention Without Physical Examination" by U.S. FDA. Products subject to detention without physical examination are held at the port of entry while U.S. FDA performs additional scrutiny, testing, and analysis. Delays from detention without physical examination may be lengthy for businesses anxious to deliver products on schedule. For assistance with a detention, simply click on the Notice of Action shown on the left.




 
U.S. FDA Regulations:

U.S. FDA Medical Device Regulation: 21 C.F.R. Part 801 et seq.

UDI-GUDID Regulations: 78 Fed. Reg. 58785, 58785-58828

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.

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