Reference

FDA Regulatory Glossary

Comprehensive reference of FDA regulatory terms, acronyms, and definitions used in FDA compliance.

61 regulatory terms and acronyms

510(k): A premarket submission made to the FDA to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device. Most Class II devices require 510(k) clearance before marketing.; 510(k) Guide

AAFCO: Association of American Feed Control Officials. A voluntary membership association of local, state, and federal agencies that regulates the sale and distribution of animal feeds and animal drug remedies.
Adulteration: A product is considered adulterated under the FD&C Act if it contains a substance that makes it injurious to health, was prepared or held under unsanitary conditions, or contains an unapproved additive. Adulterated products are subject to FDA enforcement.; FDA Inspection Prep Guide
AEM (Adverse Event Management): The process of collecting, evaluating, and reporting adverse events and product complaints to the FDA. Mandatory for dietary supplements, cosmetics under MoCRA, drugs, and medical devices.; AEM Dashboard
ANDA (Abbreviated New Drug Application): An application submitted to the FDA for approval of a generic drug product. ANDAs demonstrate that the generic drug is bioequivalent to a previously approved reference listed drug.
API (Active Pharmaceutical Ingredient): Any substance or mixture of substances intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient of the drug product.; Drug Registration Guide

Bioterrorism Act: The Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Requires domestic and foreign food facilities to register with the FDA and mandates prior notice for imported food shipments.; Food Facility Registration
BLA (Biologics License Application): A request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce. Filed under Section 351 of the Public Health Service Act.

CFR (Code of Federal Regulations): The codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the federal government. Title 21 CFR covers food and drugs.
cGMP (current Good Manufacturing Practice): Regulations enforced by the FDA that provide a system of processes, procedures, and documentation to assure a product has the identity, strength, composition, quality, and purity it is represented to possess. Found in 21 CFR Parts 210, 211 (drugs), 820 (devices), and 117 (food).; Compliance Calculator
CoA (Certificate of Analysis): A document issued by a quality assurance department confirming that a regulated product meets its product specification. Includes results of each test performed on the product, along with the specifications for those tests.
CTE (Critical Tracking Event): Under FSMA Section 204 (Food Traceability Rule), a CTE is an event in the food supply chain that must be documented with Key Data Elements for traceability purposes, such as growing, receiving, transforming, creating, and shipping.; FSMA Compliance

DMF (Drug Master File): A submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs.
DSHEA (Dietary Supplement Health and Education Act): The 1994 act that amended the FD&C Act to establish the regulatory framework for dietary supplements. Under DSHEA, dietary supplements are regulated as a category of food, not as drugs.; Supplement Compliance
DUNS Number: A unique nine-digit identifier assigned by Dun & Bradstreet to business entities. Required by the FDA for establishment registration and often used alongside the FEI number for facility identification.; FEI & DUNS Helper

EIR (Establishment Inspection Report): A report prepared by an FDA investigator after conducting an inspection of a regulated facility. The EIR documents observations, conditions, and findings from the inspection.; Inspection Prep Guide
EUA (Emergency Use Authorization): An authorization issued by the FDA Commissioner that allows unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases.

FD&C Act (Federal Food, Drug, and Cosmetic Act): The primary federal law governing the safety and regulation of food, drugs, medical devices, and cosmetics in the United States. Originally enacted in 1938 and amended numerous times, including by FSMA, DSHEA, and MoCRA.
FDA (Food and Drug Administration): A federal agency within the U.S. Department of Health and Human Services responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food, cosmetics, and tobacco products.
FEI (FDA Establishment Identifier): A unique number assigned by the FDA to identify each physical establishment that manufactures, processes, packs, or holds FDA-regulated products. Required for registration and inspections.; FEI & DUNS Helper
FSMA (Food Safety Modernization Act): Signed into law in 2011, FSMA is the most sweeping reform of U.S. food safety laws in over 70 years. It shifts the focus from responding to contamination to preventing it and includes rules for preventive controls, produce safety, FSVP, and food traceability.; FSVP Compliance Guide
FSVP (Foreign Supplier Verification Program): A FSMA rule requiring U.S. importers to verify that food imported into the United States meets applicable U.S. safety standards. Importers must develop and maintain an FSVP for each food and each foreign supplier.; FSVP Compliance Guide
FTL (Food Traceability List): A list published by the FDA under FSMA Section 204 identifying foods for which additional traceability records are required. Includes foods such as fresh-cut fruits and vegetables, shell eggs, nut butters, and certain cheeses.
FURLS (FDA Unified Registration and Listing System): The FDA's electronic system for facility registration and product listing. Used for food, drug, device, and tobacco establishments to submit and manage their registration and listing information online.; Registration Services

GMP (Good Manufacturing Practice): A system of regulations, codes, and guidelines for the manufacture of drugs, medical devices, food, and active pharmaceutical ingredients. See also cGMP.; Compliance Checklist
GRAS (Generally Recognized as Safe): A designation that a chemical or substance added to food is considered safe by experts and is therefore exempt from the usual Federal Food, Drug, and Cosmetic Act food additive tolerance requirements.; Ingredient Checker

HACCP (Hazard Analysis Critical Control Points): A management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production through manufacturing, distribution, and consumption. Required for juice and seafood processors.
HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Products): Products that contain or consist of human cells or tissues intended for implantation, transplantation, infusion, or transfer into a human recipient. Regulated by the FDA under 21 CFR Parts 1270 and 1271.

Import Alert: A notice issued by the FDA to its field staff and the public that provides guidance on admissibility of imports. Import alerts may instruct the agency to detain products without physical examination (DWPE) based on past violations.; Import Alert Checker
IND (Investigational New Drug): An application submitted to the FDA before a new drug can be studied in humans. The IND application includes data from animal pharmacology and toxicology studies, manufacturing information, and clinical protocols.

KDE (Key Data Element): Under the FSMA Food Traceability Rule (Section 204), KDEs are the specific data points that must be recorded at each Critical Tracking Event, such as lot codes, quantities, locations, and dates.

Labeling: All labels and other written, printed, or graphic material on a product or any of its containers or wrappers, or accompanying the product. The FDA defines labeling broadly to include promotional materials, websites, and package inserts.; Labeling Reviewer Tool
Listing Number: A unique number assigned to each product listed with the FDA. Drug products receive an NDC number, while device and food products receive product listing numbers through the FURLS system.; Registration Services

MDUFA (Medical Device User Fee Amendments): Legislation that authorizes the FDA to collect user fees from medical device companies to fund the review of device applications, including 510(k)s, PMAs, and De Novo requests. Reauthorized periodically.; Medical Devices
Misbranding: A product is considered misbranded under the FD&C Act if its labeling is false or misleading, does not include required information, or does not conform to required standards. Misbranded products are subject to FDA enforcement actions.; Labeling Reviewer
MoCRA (Modernization of Cosmetics Regulation Act): Enacted in December 2022 as part of the Consolidated Appropriations Act, MoCRA is the most significant expansion of FDA authority over cosmetics since 1938. It requires facility registration, product listing, adverse event reporting, safety substantiation, and GMP compliance for cosmetics.; MoCRA Compliance Guide

NDA (New Drug Application): The formal application submitted to the FDA requesting approval to market a new drug in the United States. The NDA includes full reports of clinical investigations demonstrating the drug is safe and effective.
NDC (National Drug Code): A unique 10-digit, 3-segment number assigned to each drug product listed under Section 510 of the FD&C Act. The segments identify the labeler, product, and trade package size. Required for all commercial drug distribution.; NDC Number Guide
NDI (New Dietary Ingredient): A dietary ingredient that was not marketed in the United States before October 15, 1994. Manufacturers must submit an NDI notification to the FDA at least 75 days before marketing a dietary supplement containing the NDI.; Supplement Compliance
NNDS (New Dietary Ingredient Notification System): The FDA system through which manufacturers and distributors submit notifications for New Dietary Ingredients (NDIs) prior to marketing. The notification must include evidence of safety.

ORA (Office of Regulatory Affairs): The lead office within the FDA for all field activities, including inspections, import operations, and enforcement actions. ORA staff conduct facility inspections and manage import alerts.
OTC (Over-the-Counter): Drugs that can be purchased and used without a prescription. OTC drugs must comply with an applicable OTC monograph or have an approved NDA/ANDA. OTC drug manufacturers must register their establishments and list their products with the FDA.; Drug Registration

PDUFA (Prescription Drug User Fee Act): Legislation that authorizes the FDA to collect fees from drug manufacturers to fund the new drug approval process. First enacted in 1992 and reauthorized approximately every five years.
PMA (Premarket Approval): The most stringent type of device marketing application required by the FDA. Required for Class III medical devices that support or sustain human life, are of substantial importance in preventing impairment, or present a potential unreasonable risk.; Medical Device Guide
Prior Notice: A requirement under the Bioterrorism Act and FSMA that advance notification must be submitted to the FDA before food is imported or offered for import into the United States. Must be submitted via the Prior Notice System Interface (PNSI) or ABI/ACS.; Prior Notice Filing Guide
Product Code: A code assigned by the FDA to classify a product by its generic identity, such as food type, device classification, or drug category. Used in registration, listing, and import operations.; Product Code Lookup

QMS (Quality Management System): A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. Required for medical device manufacturers under 21 CFR Part 820 (QSR) and the new QMSR.
QMSR (Quality Management System Regulation): The FDA's updated regulation for medical device quality systems, harmonized with ISO 13485:2016. Replaces the former Quality System Regulation (QSR) under 21 CFR Part 820 and took effect February 2, 2026.; Medical Devices

Recall: An action taken by a firm to remove a product from the market. Recalls may be conducted voluntarily by the manufacturer or at FDA request. The FDA classifies recalls as Class I (most serious), Class II, or Class III based on the level of health hazard.
Registration: The process by which domestic and foreign establishments that manufacture, process, pack, or hold FDA-regulated products must register with the FDA. Food facilities must renew biennially (Oct 1 - Dec 31 of even-numbered years). Drug and device establishments register annually.; Registration Services
Responsible Person: Under MoCRA, the manufacturer, packer, or distributor whose name appears on the cosmetic product label and who is responsible for adverse event reporting, safety substantiation, and compliance. Must have a U.S. contact person or U.S. agent.; MoCRA Compliance

SNDA (Supplemental New Drug Application): An application submitted to the FDA to request approval for changes to an already approved drug product, such as new indications, dosage forms, strengths, routes of administration, or labeling revisions.
SPL (Structured Product Labeling): An XML-based standard for exchanging product labeling content. The FDA requires drug product labeling, including OTC monograph drug listings and NDC submissions, to be submitted in SPL format via the FDA ESG.; Drug Registration
Structure/Function Claims: Claims on dietary supplement labels that describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body (e.g., 'calcium builds strong bones'). Must include the disclaimer that the statement has not been evaluated by the FDA.; Supplement Labeling Guide

Traceability: The ability to track and trace the movement of food products through the supply chain. FSMA Section 204 (Food Traceability Rule) requires additional recordkeeping for foods on the Food Traceability List, using CTEs and KDEs.

UDI (Unique Device Identification): A system created by the FDA to adequately identify medical devices through their distribution and use. Each device label must include a UDI, which consists of a Device Identifier (DI) and a Production Identifier (PI).; UDI Lookup Tool
US Agent: A person residing or maintaining a place of business in the United States that a foreign establishment designates as its agent for FDA communications. Required for all foreign facilities registered with the FDA, including food, drug, device, and cosmetics establishments.; US Agent Services
USDA (United States Department of Agriculture): The federal department responsible for developing and executing policy on farming, agriculture, forestry, and food. The USDA's Food Safety and Inspection Service (FSIS) regulates meat, poultry, and egg products, while the FDA regulates most other foods.

VQIP (Voluntary Qualified Importer Program): A voluntary, fee-based FDA program that provides expedited review and entry of food imports for participating importers who have demonstrated a high level of control over the safety and security of their supply chains.; Food Import Compliance

Warning Letter: A written communication from the FDA to a firm or individual notifying them of significant regulatory violations. Warning letters request that the recipient take corrective action and respond within 15 business days.; Warning Letter Search
WHO (World Health Organization): A specialized agency of the United Nations responsible for international public health. WHO publishes guidelines on GMP, pharmaceutical quality, and regulatory convergence that influence FDA standards.

Need Help with FDA Compliance?

Our regulatory experts can help you navigate complex FDA requirements. Get started with a free compliance assessment.

Start My Compliance Check Talk to an Expert

Trusted by 2,800+ companies worldwide

FDA Regulatory Glossary

Glossary Terms

Need Help with FDA Compliance?