US FDA Registration For Medical Devices

US FDA Registration process varies depending on the type of product but generally involves an annual or biannual, if commercially available, distribution in the US Market. We are a US FDA registration Consultant supporting worldwide manufacturers & distributors, simplifying a comprehensive and often frustrating and complicated online US FDA Registration Certificate and listing formalities.

FDA (Food and Drug Administration)

The Food and Drug Administration of the United States (US FDA) is responsible for protecting public health by ensuring the safety, efficacy, and security of Food Supply, Drugs and Biological(s), Medical Devices, Cosmetics, Radiation Equipment, and Tobaccos by regulating the manufacturing, marketing, and distribution.

Owners or operators of places of business (also called FDA ESTABLISHMENTS or FACILITIES) that Manufacture, Repack, Relabel, Export, or Import products in the aforementioned industries must REGISTER their facilities with the US FDA. The FDA Registration process varies depending on the type of product but generally involves an annual or biannual, if commercially available, distribution in the US.


  • Food / Nutraceutical / Food Supplements

  • Drugs / API,s / Testing Labs / Compounding Pharmacy

  • Medical Device Manufactures / Initial Exporters / Initial Importers

  • Cosmetic Manufactures and Brand Owners

FDA Food Facility Registration

The FDA Food Registration in the United States is effective as of December 12, 2003. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, also known as the “Bioterrorism Act,” instructs the Department of Health and Human Services’ food regulatory agency. The so-called Food and Drug Administration (US FDA) will take action to protect the public from a terrorist assault on the US food supply, as well as other food-related emergencies.

To comply with the above provisions of the Bioterrorism Act, FDA established the following mandatory regulations:

  • All Food Facilities Register with FDA so-called “FDA Registration.”
  • Prior information on shipments of imported food to FDA so-called “Prior Notice.”

Manufacturers, distributors, owners, operators, or agents in charge who are responsible for the selling of food for use in the United States must register the facility with the FDA. The FDA is responsible for ensuring that foods sold in the United States are nutritious, wholesome, and properly labeled under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Equal Packaging and Labeling Act.

FDA Food Facility Registration can be completed in less than 8 hours.  The laws refer to both domestically grown foods and foods imported from other countries.

Types of FDA Inspection & Audit

FDA intends to protect the public from unsafe products; the below four different types of inspections conducted

    • Food Facility Registration Free of Cost. We charge only for the US Agent Service.
    • Free US Food Facility Registration Certificate
    • Food Labeling Review
    • Advance information on imports to the U.S through “Prior Notice”.
    • Telephonic Guidance for filling the form
    • You and your clients can search and verify FDA Food Registration and certificate Validity status from our website.

US (FD & C Act) [21 U.S.C. 350d] Section 415 requires food facilities required to register with the FDA to renew such registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year. The next renewal is from 1st October 2022, 12:01 AM through 31st December 2022, 12:59 PM.

We guide FDA Food Facility Renewal of your existing registration.

The Federal Food, Drug, and Cosmetic Act (FD & C Act) and the fair packaging and labeling act are under FDA’s jurisdiction and are responsible for assuring that foods sold in the United States are safe, wholesome and properly labeled. The laws apply to foods produced domestically, as well as foods from foreign countries.

The Food product manufacturer or Distributor of the Food product is responsible for making sure food is properly labelled according to the FDA,s ” Guidance for Industry: Food Labeling Guide” requirements. You will not be permitted to send the label before shipping, nor FDA will not approve any food label.

If the labels are NOT complying during the time of entry to U.S.A port or during sales US FDA will consider the product as MISBRANDED and may take regulatory action, including the detention of your food item.

How can we help you?

In this regulatory maze, it would be complicated for the manufacturer to make sure the substance complies with the regulation and issue a certificate of compliance covering all the required details to a client to gain their confidence. Any incorrect act of the manufacturer would strictly lead to a penalty from FDA, considering these to be food contact substances affecting a huge population. It is best advisable to contact consultant experts in the field first to analyze the substance formulation if complying with the FDA regulations and the 21 CFR part number it falls into or its CAS number. We, as consultants, can provide you with the list of tests that needs to be conducted on the substance to demonstrate compliance where ever needed and a product review report explaining which regulations the substance complies to.

How to issue a compliance certificate?

Manufacturers can issue a compliance certificate in compliance with Section 303 c (2) of the Federal Food and Drug Cosmetic act. This section clearly states that penalties are laid down for violations of the act. According to this section, manufacturers can provide a “Letter of guaranty” to their clients that their substance complies with the regulations laid down by the FDA. The suggested formats for the letter of guaranty are available as in 21 CFR 7.13, where the letter can be issued for a specific shipment or delivery or be given as a part of the invoice or bill. Suggested formats for domestic and foreign manufacturers or agents are available in this section. There is no need to make the guarantee statement in the labeling.

Commercial food processors are responsible for ensuring the safety of their products.  Hazards that can occur if inadequate or improper manufacturing, processing, or packaging are used to produce low-acid and acidified canned foods. Therefore, food processors must comply with regulations established by the Food and Drug Administration (FDA) and state agriculture and health departments across the country. Any commercial food manufacturer processing and packaging low-acid canned foods and acidified foods must register their processing establishment and file processing information.

This is done to comply with laws and regulations requirements. These regulations ensure consumer safety from undesirable microorganisms or their toxins. This microorganism produces a deadly toxin if it is not properly destroyed with good canning procedures that include a properly designed thermal process.

Since filing the processing information for low-acid foods and acidified foods is an FDA requirement, the processors and importers may need to determine, among other factors, the pH and/or the water activity of the product. These two factors, at the proper safety level, are significant for protection against harmful bacteria. The safety level for pH is 4.6 or below, and for water, activity is 0.85 or below.

All commercial acidified and low-acid canned food processors in the United States and all processors in other countries who process acidified or low-acid canned food products for export to the United States must register with the FDA. Processing plants must also submit process filing forms containing scheduled process information for each acidified and low-acid canned food produced and must meet all other requirements of the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act.

Note: – Importers, wholesalers, distributors, brokers, etc., are excluded from the requirement to register.

We can assist you in:

  • Food Canning Establishment Registration
  • Process Filing
  • Labelling Review

As per US FDA Chapter VII, section 721, color additives, except coal tar hair dyes, are subject to FDA approval before they are used in food, drugs, cosmetics, or medical devices.
US FDA insists manufacturers of the above should batch certify the color additives before selling the product in the USA to use in human beings and animals.

A Colour certificate is issued after FDA chemists analyzed a sample from the batch and have found that it meets the requirements for composition and purity stated in the regulation.

Colour Additives for Use in the United States

Our consultants help companies by guiding them in

  • Identifying the color code and relevant requirements
  • Help in filling the application
  • Selection of batches/lots for testing
  • Answering concerns raised by FDA, if any, in consultation with the company team.

The guidance Fees start from 1500 USD. The fee for color batch certification is based on the weight of the batch.

A food additive is any substance added to food directly or indirectly to become a component or otherwise affect the characteristics of any food. In wider meaning, “any substance used in the production, processing, treatment, packaging, transportation or storage of food.”

Direct food additives are those that are added to a food for a specific purpose in that food. For example, xanthan gum — used in salad dressings, chocolate milk, bakery fillings, puddings, and other foods to add texture — is a direct additive. Most direct additives are identified on the ingredient label of foods.

Indirect food additives are those that become part of the food in trace amounts due to its packaging, storage, or handling. For instance, minute amounts of packaging substances may find their way into foods during storage. Food packaging manufacturers must prove to the U.S. Food and Drug Administration (FDA) that all materials coming in contact with food are safe before they are permitted for use in such a manner.

US FDA regulates the Food Addictive by LAW. We can help you to understand how and what needs to be done to comply with US Law.

First Time FDA Food Facility Registration Process

To full fill, the requirement, (a) Food Manufactures, (b) Food Exporters, (c) Exporters with Warehouses must compulsorily register their facility with US FDA.

Our US AGENT & Consulting Service helps to complete the FDA Registration and Certification within a short time.

After completing FDA Food Facility Registration, you can look up FDA registration status from the below link.

Fda Drug Establishment Registration

A drug, in general, is any substance that may alter normal bodily function when administered into the body, either internally or externally, for the treatment, mitigation, or prevention of any disease or condition in a living organism. There is no single, precise description since drug control legislation, government laws, medicine, and colloquial use all have different definitions.

We are FDA regulatory consultants who are fast and cost-effective.

    • US FDA GMP Consultancy for Pharmaceuticals and API,s
    • US FDA pre-audit inspection
    • US FDA post-audit support for closing 483’s
    • US FDA facility design for the manufacturing of drugs
    • US FDA establishment registration
    • US FDA drug listing
    • US Agent service

Regulatory requirements describe what is necessary for a new drug to be approved for use in patients, further; it requires environment, process controls, documentation, and quality system requirements for the manufacturing of drugs and cosmetics.  The Food and Drug Administration in the United States of America is responsible for establishing and monitoring these regulatory standards. The nuances of the rules, as well as their own mechanisms for gaining regulatory approval, make it extremely difficult to obtain and comply with the requirements. Due to the growing costs of meeting various country requirements, an International Conference on Harmonization was created (ICH).

In the United States of America, it is the function of the Food and Drug Administration to establish and monitor these regulatory requirements. The complexities in the laws and their own methods for obtaining regulatory approval make the task of getting and complying with the requirements made very difficult. The rising cost of meeting various country requirements led to the establishment of an International Conference on Harmonization (ICH). The ICH came up with common requirements accepted by all.

National Drug Code (NDC)

National Drug Code (NDC Code)is a ten-digit unique product identifier number for human drugs.

  • The first segment (4 or 5 digits) of the NDC Labeler code (NDC Code) identifies the establishment. (manufacturer, packer, labeler, etc. )
  • The second segment of the NDC Labeler code identifies the drug (strength, dosage, and formulation)
  • The third segment of the NDC Labeler code identifies the package size and package type

The second and third segments of the NDC Code are assigned by the labeler/owner.

NDC code requests to FDA should submit in SPL (structured Product Labelling) format via FDA ESG (electronic submission gateway).

Drug Listing

Domestic and foreign drug manufacturing and Brand owners must list all drugs produced, prepared, propagated, compounded, or processed for commercial distribution in the United States of America along with drug establishment registration. All foreign drug establishment registration must also recognize a US Agent.

FDA Drug Label Review

Drugs must be labeled according to FDA Regulations. We offer Label review services. Our Label review team works in 3 shifts, 24 X 7, and completed more than 2800+ reviews so far across the globe.

The Food and Drug Administration (FDA) is responsible for assuring that foods sold in the United States are safe, wholesome, and properly labeled. … It is the responsibility of the food industry to remain current with the legal requirements for food labeling.

We help manufacturers and Distributors to complete Drug Establishment Registration, NDC Code request to FDA will complete in a matter of 14 working days approximately. We also review the drug label before listing it.

Before being distributed, API and homeopathic drugs should also complete the FDA Drug Listing.

Establishment Registration & Device Listing

For US FDA, Class I was exempted and Class I, II & III 510k cleared FDA Medical Device Registration.

The following type of establishments can register, list and market the medical device in the United States of America:

  1. Contract Manufacturer
  2. Contract Sterilizer
  3. Foreign Exporter
  4. Initial Distributor
  5. Manufacturer
  6. Repackage
  7. Relabelers
  8. Remanufacturer
  9. Preprocessors of Single-Use Devices
  10. Specification Developer
  11. U. S. manufacturer of export only devices

The Route of FDA Medical Device Registration

FDA Medical Device Registration

Those involved in the manufacture and sale of FDA medical devices for commercial distribution in the United States must register with the FDA annually. The majority of establishments that are expected to register must also list the devices.

If a device requires premarket approval or notification before being marketed in the U.S., the owner/operator should also submit the FDA premarket submission number/510k. The requirements for FDA Medical Device Registration and listing are based on the type of activity performed at that establishment. All initial importers must review the list of manufacturers of your imported devices. All foreign establishments must review your list of known importers for each of your exported devices. If this information has not been entered previously, it must be entered during the annual registration period to complete registration for the current fiscal year.

Cosmetic Facility Registration (US FDA)

Cosmetics are exempted from FDA premarket approval or mandatory establishment registration or ingredient reporting. The manufacturer’s responsibility is to ensure that their cosmetic products and ingredients are safe and properly labeled, fully compliant with US FDA regulations.

The Voluntary Cosmetic Registration Program (VCRP) is an FDA post-market reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the US. There are two parts to the FDA Voluntary Cosmetic Registration program; you may participate in both parts of the program or only one part.

The VCRP applies only to cosmetic products sold in the United States. It does not apply to cosmetic products for professional use only, such as products used in beauty salons, spas, or skincare clinics. It also does not apply to hotel samples or gifts, or cosmetic products you make in your home to sell to your friends.

Cosmetic Facility registration with the US FDA

We help manufacturers and packers interested in registering their establishments with US FDA to sell their products in the US market. Distributors are not allowed as per the law.

FDA assigns a registration number to each manufacturing establishment registered and sends you a receipt.

Cosmetic Product Ingredient Statements (CPIS) Filing with FDA

We help manufacturers, packers, private labelers, or distributors file a statement for each product the firm has entered into commercial distribution in the United States.


Test the product as per standard and make sure the safety and quality of the product. Export of food to other countries is increasingly subject to scrutiny, testing to ensure compliance with food safety regulations of the respective countries.

Our labs are accredited and widely accepted by all regulatory authorities. We provide testing for US FDA related submissions and clearances.




Light Transmittance

As per Client Requirement

5 days

Dissolvent residue test

As per Client Requirement

5 days

Microbiological tests

As per Client Requirement

15 days


As per Client Requirement

30 days

Penetration of Water Vapour

As per Client Requirement

5 days

Penetration of Oxygen

As per Client Requirement

5 days

Heavy Metals

As per Client Requirement

15 days

Maximum extractable fraction

As per Client Requirement

10 days

Total Extractive test

As per Client Requirement

5 days

Water vapour transmission rate

As per Client Requirement

5 days

Bursting strength

As per Client Requirement

5 days

Peel strength

As per Client Requirement

5 days


As per Client Requirement

5 days


As per Client Requirement

5 days

Identification of shellac coating (if used)

As per Client Requirement

5 days

Food Ingredient Identification

As per Client Requirement

15 days

Stability Studies (1 / 2/ 3/ 4 /5) Years

Accelerated Conditions
Under Ambient conditions


Is It Really FDA Approved?  – useful Information
Food Additives & Ingredients – Useful Information