About FDA

FDA Overview
FDA Organization Chart
FDA inspections and applications
FDA NSF CTFA CE Inspection Registration Certification Approval

foodstuffs
cosmetics
medical equipment
medical supplies
chemicals

FDA Overview

Food and Drug Administration

FDA（米国食品医薬品局）の概要

Established in 1927 as the Food, Drug, and Insecticide Administration and renamed to its current name in 1930, it is the oldest consumer protection agency in the United States. As a federal agency, it establishes safety standards for medical devices, household equipment, chemicals, cosmetics, food additives, food products, and pharmaceuticals, and conducts inspections, testing, and approvals.

FDA's primary business

■ Take the necessary legal action to restrict the sale of unapproved products or discontinue the sale of harmful products.
■ Through litigation, we also seize hazardous products and prosecute companies that violate laws and regulations.
■ In accordance with the Federal Drug and Cosmetic Act, we develop safety and purity standards, conduct factory inspections and enforce legal regulations.
■ Require that product information be accurately labeled in accordance with packaging and product labeling standards.
■ Under the Public Health Law, it has the authority to supervise vaccines and sera, and can also sterilize milk and conduct sanitary inspections of restaurants and lodging facilities.
■ The Radiation Regulation Law regulates radiation emitted from X-ray devices, televisions, microwave ovens, etc., to protect consumers.

FDA Related Research Centers

1. Center for Food Safety and Applied Nutrition (CFSAN)

Regulates the safety of all food products and cosmetics consumed in the United States. For food products, we verify purity and sanitary conditions, and for cosmetics, we ensure that there are no adulterants and that proper quality controls are in place.

To reduce the incidence of food safety incidents, the HACCP system has been introduced and is required to be implemented in all industries, beginning with the fishing industry.

HACCP(Hazard Analysis and Critical Control Point) is a system for processors to analyze and prevent hazards in their products and to monitor and record control measures.

Center for Drugs and Biologics (CDB)

We protect and improve public health through the regulation of biologics, including blood, vaccines, and therapeutics, and their related drugs and devices. We evaluate these products for purity, efficacy, and suitability for use from scientific and legal perspectives.

3. center for medical device and radiation health (CDRH)

Conducts experimental investigations based on the potential hazards of radiation and promotes the safe use of radiation. Develops evaluation methods and measuring instruments for radiation generating equipment and products.

Medical devices are classified as Class I, II, or III according to safety and effectiveness and require pre-marketing notification and approval. It also establishes standards of practice for radiation generating devices, provides guidelines for their use to prevent unnecessary radiation exposure, and provides consumers and manufacturers with accurate information about medical devices and radiation generating products.

4. center for veterinary medicines (CVM)

We test veterinary drugs and feeds for efficacy and safety (including antibiotic use), test for residues to ensure the safety of livestock food products, and evaluate the efficacy and safety of veterinary drugs.

FDA Organization Chart

FDA組織図

Center for Food Safety and Applied Nutrition (CFSAN)

It regulates the safety of all food and cosmetic products consumed in the United States. It also sets regulatory standards for product ingredients and manufacturing processes.

Center for Drugs and Biologics (CDB)

Regulates biological products, including blood products, vaccines and therapeutics, and related pharmaceuticals and medical devices to protect and improve public health. We evaluate these products for purity, safety, efficacy, and suitability for use from scientific and legal perspectives.

Center for Devices and Radiological Health (CDRH)

It classifies medical devices into Class I, II, and III based on safety and efficacy, and conducts pre-marketing notification and approval reviews. It also establishes standards of practice for radiation generating devices, sets guidelines for their use to prevent unnecessary radiation exposure, and provides accurate information on medical devices and radiation generating products to consumers and manufacturers.

Center for Veterinary Medicine (CVM)

We test veterinary medicines and feeds for efficacy and safety (including the use of antibiotics), test for residues to ensure the safety of livestock food products, and evaluate the efficacy and safety of veterinary medicines.

National Center for Toxicology Research (NCTR)

Research on biochemical indicators of carcinogenicity, toxic emission studies, studies of the influence of genetic factors and developmental effects, studies of carcinogenic factors, mutation studies, toxicological studies, epidemiological studies, studies to detect immune system abnormalities, toxicity evaluation of chemical mixtures, biostatistical analysis, statistical analysis of genetic material, mixtures to identify potential hazards substances, and other studies.

Six major city regional offices

21 District Office

130 local offices

FDA inspections and applications

FDA登録・検査フローチャート

FDA Regulatory Guide by Item

Please switch the tabs below to confirm.

FDA規制ガイド

In contrast to the ex-ante regulatory system in Korea and Japan, the U.S. adopts an ex-post regulatory system. Therefore, if an illegal matter is found after the fact, a strong penalty will be imposed, which may have a serious impact on the survival of the exporting company. Therefore, FDA inspections are mandatory.

1. general food inspection requirements

Required inspection items (3 items)

component test

Confirmation of product composition
Safety Assessment

Nutritional Analysis

Analysis of essential nutrients
Acquisition of data for Nutrition Facts labeling

Heavy Metal Testing

Including pesticide residue testing
Confirmation of conformity with safety standards

More about Nutritional Analysis Testing

Nutrition Facts Creation Procedure

Conduct and analyze inspections
Creation of packaging designs based on data
Proper labeling on products

Basic Nutrition Facts

Calories (including fat calories)
Fat (saturated fatty acids, trans fat)
cholesterol
carbohydrate

Additional Nutrition Facts

Dietary fiber, sugar, water
Salts, protein
Vitamins A and C
Sodium, calcium, iron

Heavy Metal Testing

Priority inspection items (8 items)

arsenic (As)
barium (Ba)
cadmium (Cd)
chromium (Cr)
lead (the metal)
mercury
selenium (Se)
silver

Significance of the Inspection

Because these heavy metals have a significant impact on the human body, strict standard values have been established.

Additional Requirements by Food

shrimp

Antibiotic testing is required.
Need to keep records of inspection results

green tea

Optional but recommended
Helping to improve consumer confidence
Nutrition Facts Labeling Promotes Choice

2. dietary supplements

Indications are prohibited (if indicated, pharmaceutical regulations apply).

FDA Dietary Supplement Guidelines(Open in new window)

Manufacturer Obligations

Conduct pre-market safety inspections
Documentation of inspection results
Establishment of quality control system

Display Requirements

Proper labeling of food labels
Accurate nutritional information
Warning sign (if required)

3. functional food

Approval Requirements

Requires separate FDA approval application
Functionality and efficacy labeling is possible
FDA-approved" labeling available

Display Requirements

Display in Supplement Facts format
Clear statement of scientific rationale
Include appropriate precautions

4. low-acid foods

Heat treatment is a prerequisite

FDA Low Acid Food Regulations(Open in new window)

Reference value requirement

pH concentration: 4.6 or higher
Water activity: 0.85 or higher

Registration Requirements

FCE (factory registration) required
SID (process registration) required

Registration Process

Application for Facility Registration (FCE)
Registration of manufacturing process (SID)
Obtaining an FCE number
Obtaining a SID number

Exempted Items

Exemption based on standard values

pH concentration 4.6 or less
Water activity less than 0.85

Exemption by item

Alcoholic beverages (with classification by alcoholic content)
carbonated drinks
fermented food
refrigerated food
Jams and jellies

FDA化粧品規制ガイド

Cosmetics Regulations Overview

The FDA's cosmetics administration is handled by the Center for Food Safety and Applied Nutrition (CFSAN).

Key Regulatory Points

Cosmetics must comply with regulations on process control, packaging and labeling
Importers are often required to present FDA inspection results
Safety testing is the most important requirement

Safety Requirements

Requires documentation to prove harmlessness to the human body
In addition to safety testing, rigorous skin testing is recommended
Particular attention should be paid to labeling that touts therapeutic or preventive effects.

Cosmetics Categorization

Classification based on 21CFR 700-740

Important Matters Concerning Display Regulations

If a cosmetic product has a label claiming therapeutic or preventive effects, it may be regulated as a drug and importation may be restricted.

Labeling Notes

Care should be taken in expressing the uses and effects of the product.
Accurate listing of all ingredients is required.
Appropriate safety warning signs

米国医療機器規制ガイド

U.S. medical device approval and licensing procedures

The U.S. medical device industry is the largest, accounting for more than 401 TP3T of the global market. As a result, many medical device manufacturers are seeking to enter the U.S. market.

Due to the nature of medical devices used directly on the human body, governments regulate market entry with strict standards. Understanding the FDA's approval and licensing procedures is essential for entry into the U.S. market.

Medical Device Laws and Regulations

Medical devices in the United States are regulated by the "Federal Food, Drug & Cosmetic Act. Commonly referred to as the "FD&C Act" or "FFD&C Act," this law has undergone major amendments since its enactment in 1938, including

1976: Medical Device Amendment
1990: Safe Medical Devices Act
1992: Medical Device Amendment
1996: FDA Export Reform and Enhancement Act
1997: Food and Drug Administration Modernization Act

Definition of medical device

Devices used for the following applications are defined as medical devices

Diagnosis, treatment, palliation, cure, and prevention of disease (human or animal)
Apparatus, machines, and devices that affect body structure and function
In Vitro Diagnostic Products

*Includes components, parts, and accessories, and shall have no chemical action or metabolic effect other than for its intended purpose.

FDA Legal Action Items

Types of legal actions taken by the FDA:

recallIf: additional information is needed to withdraw the hazardous product from the market or to ensure safe use of the product
warning letterNotice to Correct: Notice to Correct Violations
subpoenaFinal warning before filing a complaint
complaintCriminal action for violation of regulations
seizureRemoval of products from the market
fineMonetary sanctions for violations (up to $15,000 per violation, up to a total of $1 million per person)

Classification of Medical Device Grades

The FDA classifies medical devices into three grades based on the level of regulation required to confirm safety and efficacy

Class I (general regulations)

Lowest risk medical devices
Examples: rubber bandages, examination gloves, surgical tables, etc.
Often exempt from pre-market declarations and quality system regulations

Class II (special regulation)

Medical devices requiring special regulations in addition to general regulations
Examples: power wheelchairs, infusion pumps, dental bone grafting materials, etc.
Usually requires pre-market declaration (510(k)) and quality system regulations

Class III (pre-market approval)

Medical devices subject to the most stringent regulations
Examples: artificial heart valves, cardiopulmonary devices, pacemakers, etc.
Requires scientific review by pre-market authorization (PMA)

Pre-Market Declaration (510(k)) and Pre-Market Authorization (PMA)

Requirements for 510(k) Applications

Proof of intrinsic equivalence with existing approved devices
Having the same intended use
Having similar technical characteristics
No new concerns regarding safety and efficacy

PMA (pre-market authorization) requirements

The most rigorous screening process
Need scientific proof of safety and efficacy
Clinical trial data must be submitted
Detailed documentation of the manufacturing process is required

Import Requirements

FDA registration required for foreign manufacturing facilities
Ongoing updating and submission of export product lists
Full compliance with U.S. regulatory requirements

FDA医薬品規制ガイド

Drug Classification and Safety Evaluation

The inspection criteria in the Medical Device Industry clearly define each item. In particular, the following points are subject to strict examination standards.

Component Analysis and Safety Assessment

Requires detailed analysis of all key ingredients, regardless of physical form: tablets, capsules, creams, lotions, liquids, etc.
Physical and chemical properties are subject to thorough inspection

Cases requiring special safety evaluation

Heavy metals as defined in the United States Pharmacopeia (USP), especially in relation to lead and mercury
Microbiological safety testing is required if there is concern about exceeding the upper limit

Drug Application Category

New Drug Applications (NDA) New Drug Application

An application to obtain prior FDA approval for the marketing of a new drug. This includes applications for newly developed compounds, substances that have never been used safely before, or for new indications.

Abbreviated New Drug Application (ANDA) Abbreviated New Drug Application

An application to seek approval for a generic drug. An application to prove that a drug is the same as a new drug already on the market.

Investigational New Drugs (IND) Investigational New Drug

New drugs used for research purposes by qualified professionals who can investigate and study the safety and efficacy of the drug
Distribution and importation in the U.S. is possible even if the drug has not gone through the approval process through a new drug application

prescription drug Prescription Drugs

Requires use by prescription by a physician, dentist, veterinarian, or other qualified dispensing practitioner
Must be labeled "CAUTION: Federal law prohibits transfer without prescription."
Drugs that are generally required to be used safely under the supervision of a medical specialist

OTC drugs Nonprescription Drugs / OTC Drugs (Over-the-Counter Drugs)

Drugs available without a prescription
Can be sold at general retail stores and drugstores
Classified into about 80 categories
Minor treatments, sunscreen lotions, etc.

Approval of OTC drugs

Most OTC drugs sold in pharmacies can be classified as OTC Drugs
Low cost and short time to FDA approval
For generic drugs, additional experimental data may be required

OTC Drug Monographs

summary

Regulatory standards including about 800 active ingredients in about 80 OTC categories
Specify dosage (single dose), formulation, labeling, testing methods, etc.
Regularly updated and new provisions added

Important Notes

Products that do not qualify as OTC monographs may be treated as prescription drugs
Approval through NDA is required for distribution of new active ingredients as OTC drugs

Import/export precautions

Every company that intends to export a pharmaceutical product to the U.S. must register the company with the FDA. In addition to product excellence, legal compliance is also an important factor.

Main checkpoints at the time of application

Completeness of component analysis data
Reliability of safety test results
Quality control system for manufacturing process
Adequacy of labeling and indication

FDA製品検査要件ガイド

FDA Product Inspection Requirements

For the following product categories, official test documentation of conformity is often required at the time of export to the FDA

Food Ingredients
Raw materials used in the formulation
Pharmaceutical raw materials
Various raw materials and additives
Metal Alloys
Coating Products
chemical

Important Notes

Inspection documents must be prepared in advance of export
FDA safety testing may be required for products that are closely related to the human body at the manufacturing site

FDA, NSF, CTFA, CE Inspection Registration and Certification Approval

FDA関連認証ガイド

Certification and approval services

Handling Certification

FDA Inspection
Certification
approval
Registration
marketing authorization

Scope of services

We inspect, approve, certify, and permit products in the following organizations

U.S. FDA
510K
USP
NSF
EPA
CTFA
BPI (Biodegradable Products Institute)
European Standards (DIN-CERTCO, OK COMPOST)

About DiDS (Direct/Indirect Process System)

We have adopted a system to select the most appropriate method to meet customer requirements and proceed through direct contact with the necessary applicable channels (FDA agents, FDA laboratories, applicable home countries, etc.). This eliminates unnecessary processes and reasonably adjusts costs and time to completion.

About FDA

FDA is a government agency under the U.S. Department of Health and Human Service (DHHS - Department of Health and Human Services). It is responsible for providing safety standards, administration, oversight, approval, and licensing for the following products for the purpose of consumer protection

Medical supplies
medical equipment
cosmetics
Food (including food additives)