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U.S. FDA Medical Device Regulations

Medical Devices

The U.S. Food and Drug Administration (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 and Listings

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 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 FDA also are required to list their devices.

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Electronic Medical Device Reporting (eMDR)

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.

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Unique Device Identifier (UDI) and Global Unique Device Identifier Database (GUDID)

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).

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Medical Device Labeling and Product Reviews

Labeling errors are one of the leading causes of FDA detentions. Registrar Corp helps companies modify medical device labeling to comply with 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 FDA.

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Data Universal Numbering System (D-U-N-S®)

The Data Universal Numbering System (D-U-N-S®) is a business identification system operated by the private company Dun & Bradstreet®. Medical device establishments with devices subject to FDA UDI requirements must obtain a D-U-N-S® number.

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Medical Device Master Files (MAF)

A Medical Device Master File is a submission to 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.

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Medical Device Color Additives and Medical Device Color Batch Certification

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 FDA.

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Certificate of Registration issued by Registrar Corp

Device establishments registered with FDA are often asked by their customers and suppliers to verify their FDA registration. A Certificate of Registration issued by Registrar Corp serves as a third party verification of your FDA registration.

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Detention Without Physical Examination ("DWPE") Assistance

Companies shipping products to the United States may find their shipments subject to “Detention Without Physical Examination” by FDA. Products subject to detention without physical examination are held at the port of entry while FDA performs additional scrutiny, testing, and analysis. Delays from detention without physical examination may be lengthy for businesses anxious to deliver products on schedule.

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Export Certificates to Foreign Governments

Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply an “Export Certificate” for products regulated by FDA. An Export Certificate is a document prepared by FDA containing information about a product’s regulatory or marketing status.

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U.S. FDA Food Facility Registration Certificate

U.S. Food Facility Registration Certificate

FDA Registration and U.S. Agent Fees

‌US Food Facility Registration:$195 (Includes Certificate)
Non-US Food Facility Registration and U.S. Agent: $695 (Includes Certificate)
‌Certificate Only: $195

Prior Notice Fees

$19.95 per shipment

Discounts available for multiple shipments.

Labeling and Ingredient Review Fees

Labeling Review: $1,495 per product
Label Creation: $1,995 per product

Discounts available for multiple products.

Food Canning Establishment (FCE) and Process Filings (SID) Fees

FCE-SID Filing Service (First Year): $1,995
FCE-SID Filing Service (Annual Renewal): $995
FCE-SID Exclusion Certificate: $399 per product

Shell Egg Registration Fee

Shell Egg Registration: $195

FDA Dairy List Fee

Dairy List Petition: $1495

Certificate of Registration Fee

Certificate of FDA Registration: $195

Food Contact Substances (FCS) Fee

Food Contact Substance Review: $1,495 per product

Color Additive and Color Batch Certification Fees

Color Additive Report: $395 per color
Color Batch Certification Filing: $295 per batch

Data Universal Numbering System (DUNS)

Registrar Corp can obtain a Data Universal Numbering System
(DUNS) Number for your facility at no cost.

U.S. FDA Medical Device Establishment Registration Certificate

U.S. Food Facility Registration Certificate

FDA Registration and Listing Fees

FDA Device Establishment Registration: $150
Official Correspondent and U.S. Agent: $995 (Annual Fee)
Device Listings: $195 per product code

Labeling and Product Review Fees

Labeling or Product Review: $1,495 per product
Label Creation: $1,995 per product

Discounts available for multiple products.

Electronic Medical Device Reporting (eMDR) Fees

Registrar Corp submits adverse event reports for Official Correspondent and U.S. Agent Clients at no cost.

U.S. FDA Drug Establishment Registration Certificate

U.S. Food Facility Registration Certificate

Unique Device Identifier (UDI) Submission Fees

Single Submission: $95
Block of 10: $495 ($49.50 per submission)
Block of 25: $995 ($39.80 per submission)
Block of 50: $1,495 ($29.90 per submission)
Block of 100: $1,990 ($19.90 per submission)
Block of 500: $7,250 ($14.50 per submission)
Block of 1000: $9,950 ($9.95 per submission)

Medical Device Master File (MAF) Fees

MAF Submission: $1,495
MAF Agent for FDA Communications: $995 (Annual Fee)

Drug Master File (DMF) Fees

DMF Submission: $1,995
DMF Agent for FDA Communications: $995 (Annual Fee)

FDA Registration and Listing Fees

FDA Drug Establishment Registration: $845
Registrant Contact and U.S. Agent: $995 (Annual Fee)
Drug Listings: $645 per listing

Self-Identification Fee

Self-Identification Submission: $995

Registrar Corp submits self-identification information to FDA for Registrant Contact and U.S. Agent Clients at no cost.

Outsourcing Facility Fee

Registration and Registrant Contact: $2995

Export Certificate Fees

Export Certificate: $195

Radiation-Emitting Electronic Device Registration

Initial Product Report: $995
Annual Report: $495
Abbreviated Report: $995
Supplemental Report: $395
Agent for FDA Communications: $695

California Safe Cosmetics Act Certificate

Cosmetic Registration and Filing Fees

Cosmetic Registration: $395

Single Filing: $695
Block of 10: $3950 ($395 per filing)
Block of 25: $5,625 ($225 per filing)
Block of 50: $6,250 ($125 per filing)
Block of 100: $7,500 ($75 per filing)

Discounts available when filing with both
FDA and the State of California.

Cosmetic/Drug Registration Fee

Cosmetic/Drug Registration: $845
Registrant Contact and U.S. Agent: $995 (Annual Fee)
Cosmetic/Drug Listings: $645 per listing

Detention Assistance

Registrar Corp's fee for detention assistance is dependent on the cause of detention. Please call for a quote.

Fees for Food Safety Services

Food Safety Plan (First Product): $1995
Food Safety Plan (Additional Products): $995
HACCP Plan Review: $1995
HACCP Plan Creation: Contact Registrar Corp
Foreign Supplier Verification Program: $1995
Foreign Supplier Verification Program Agent: $195 per shipment
Voluntary Qualified Importer Program: Contact Registrar Corp
Food Defense Plan: $1995
Mock FDA Inspection: Contact Registrar Corp

Tobacco Registration and Listing Fees

Authorized Agent: $495
Tobacco Facility Registration: $195

Single Listing: $195
Block of 10: $1,750 ($175 per listing)
Block of 25: $3,750 ($150 per listing)
Block of 50: $6,250 ($125 per listing)
Block of 100: $9,500 ($95 per listing)


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