Product regulation

Food and Drug Administration

Food, drugs, biological products, medical devices, cosmetics, animal products and radiation-emitting electronic products have distinct FDA pathways. Product category and intended use are essential to identifying the applicable requirements.

Read the source in its own scope

Food and Drug Administration is represented in this collection through the specific publications listed below. Begin with the product, activity and responsible party identified by the source. A reference to an agency does not establish that every product in an industry follows the same pathway. Scope, definitions, exceptions and the status of an adopted technical document can change the conclusion.

Connect the publication to the product decision

Use the original publication to establish the requirement, then connect it to the actual model, configuration, process or transaction. Keep source dates separate from effective and compliance dates. Where several agencies are relevant, preserve a distinct conclusion for each framework. A test report, registration, approval, certification and voluntary program claim should be assessed for the precise object and conditions they cover.

26 source profiles

Publications and requirements in this collection

Federal regulationFDA

Acidified Foods: Scheduled Processes and Acidification Controls

21 CFR Part 114; 21 CFR 108.25

Acidified-food controls address low-acid ingredients brought to an equilibrium pH within the regulatory definition, together with water-activity and product-category considerations. Part 114 covers scheduled processes, supervision, pH control, container handling, deviations and records. Part 108 adds registration and process-filing duties. Product classification is essential because naturally acid foods, refrigerated products and low-acid canned foods can follow different provisions.

Food & Beverages

Federal regulationFDA

Animal Food and Pet Food: CGMP and Preventive Controls

21 CFR Part 507

Part 507 covers current good manufacturing practice and risk-based preventive controls for animal food, including pet food and feed for food-producing animals. The food, target species and manufacturing activity affect the hazard analysis. Covered operations establish a written food safety plan and supporting controls, while farms, qualified facilities, particular storage activities and human-food by-products require careful applicability analysis.

Animal Food & Veterinary Products

Federal regulationFDA

Animal Food and Pet Food: Labeling and Claims

21 CFR Part 501; FD&C Act labeling and animal-drug provisions

Animal-food labeling identifies the product, quantity, responsible business and ingredients, while claims can affect its regulatory classification. Pet foods and livestock feeds are subject to federal requirements and potentially additional state registration and labeling rules. AAFCO model provisions are influential but are not themselves a federal approval system. Disease-treatment claims can raise new-animal-drug questions beyond ordinary food labeling.

Animal Food & Veterinary Products

Federal regulationFDA

Biological Products: General Controls and Product Standards

21 CFR Parts 600 and 610; related licensure provisions in Part 601

Biological products combine manufacturing controls with product-specific evidence and licensure responsibilities. Parts 600 and 610 address general establishment matters, records and biological-product standards. Their application must be read with the licensing framework and any more specific product rules. Sterility, potency, identity and purity have distinct regulatory roles; a generic laboratory panel cannot establish the complete position for every biologic.

Pharmaceuticals & Biologics

Federal regulationFDA

Conventional Food Nutrition Labeling

21 CFR 101.9 and 101.12

Nutrition labeling connects serving-size rules, nutrient declarations, daily values and presentation requirements. A technically correct nutrient calculation does not by itself establish a compliant label. Product category, package size, claims and exemptions affect the analysis. FDA’s current industry resources should be read with the regulation; its older Food Labeling Guide expressly warns that its nutrition chapter is not fully updated.

Food & Beverages

Statutory or administrative frameworkFDA

Cosmetics: MoCRA Registration, Listing and Safety Responsibilities

FD&C Act sections 605–609 and 612, as added by MoCRA

MoCRA expanded FDA’s cosmetics authorities and imposed responsibilities concerning adverse events, safety substantiation, facility registration and product listing. Covered facilities and responsible persons have different roles. Registration and listing are operational reporting requirements, not approval of products or facilities. Exemptions must be assessed against the statutory conditions, while separate rulemaking subjects must be tracked according to their actual status.

Cosmetics & Personal Care

Federal regulationFDA

Cosmetics: Product Identity, Ingredients and Label Presentation

21 CFR Part 701; related warnings in Part 740

Cosmetic labeling combines product identity, business information, net contents and ingredient declarations with readable presentation. Requirements differ between the immediate container and outer retail packaging, and particular exceptions must be checked carefully. A truthful cosmetic label also depends on the product’s intended use: therapeutic or body-function claims can raise drug requirements. MoCRA adds responsibilities that must be considered alongside the established labeling rules.

Cosmetics & Personal Care

Federal regulationFDA

Dietary Supplement Manufacturing, Packaging, Labeling and Holding

21 CFR Part 111

Part 111 establishes a production and quality-control system for dietary supplements. Its requirements cover personnel, premises, equipment, components, specifications, manufacturing records, testing, packaging, labeling and complaints. The rule concerns the supplement’s identity, purity, strength, composition and contamination limits. CGMP compliance does not resolve whether an ingredient, label statement or therapeutic claim is legally permissible.

Dietary Supplements

Federal regulationFDA

Dietary Supplements: New Dietary Ingredient Notifications

21 CFR 190.6; FD&C Act section 413

A new dietary ingredient raises a safety-notification question separate from supplement manufacturing and labeling. The manufacturer or distributor must determine whether notification is required for the ingredient and its intended use. FDA receives information supporting a reasonable expectation of safety at least 75 days before the applicable introduction into interstate commerce. A notification response does not approve the supplement.

Dietary Supplements

Agency guidanceFDA

Drug Stability: FDA ICH Q1A(R2) Guidance

FDA guidance Q1A(R2), November 2003; 21 CFR 211.166

FDA’s final Q1A(R2) guidance describes a stability-data package for new drug substances and products within its scope. It addresses study design, batches, containers, storage conditions, testing intervals and evaluation. Stability evidence supports a retest period or shelf life and proposed storage instructions. The separate consolidated Q1 document checked for this brief is explicitly draft and must not be presented as a final replacement.

Pharmaceuticals & Biologics

Recognition or voluntary programFDA

FDA Recognized Consensus Standards for Medical Devices

FD&C Act section 514(c); FDA Recognized Consensus Standards Database

FDA recognizes consensus standards for specified uses in medical device premarket review. The recognition record identifies the standard and relevant conditions, including complete or partial recognition. Recognition is distinct from incorporation into regulation and from approval or clearance of a device. A manufacturer must connect the selected edition and recognized provisions to the intended device and the evidence submitted.

Medical Devices & Diagnostics

Federal regulationFDA

Finished Pharmaceuticals: Current Good Manufacturing Practice

21 CFR Parts 210 and 211

Drug CGMP establishes the systems and controls used to produce medicines with their intended identity, strength, quality and purity. Part 210 provides general applicability, while Part 211 addresses finished pharmaceuticals. Responsibilities extend beyond finished-product testing to the quality unit, materials, facilities, production, laboratory operations, packaging and records. Product and activity-specific provisions must be considered alongside these general requirements.

Pharmaceuticals & Biologics

Federal regulationFDA

Food Contact Substance Notifications and Conditions of Use

21 CFR 170.100–170.106; FD&C Act section 409(h)

The food contact notification system is a defined premarket route for certain substances used in food-contact materials. Its scope is tied to the notified substance, intended use and identified manufacturer or supplier. FDA’s inventory must be read with the notification’s limitations and effectiveness status. An effective notification is not a general approval of every finished package using a similar material.

Food & Beverages

Federal regulationFDA

Foreign Supplier Verification Programs for Food Importers

21 CFR Part 1, Subpart L

FSVP places risk-based verification responsibilities on the defined U.S. importer of food. The program links the food’s hazards, the foreign supplier’s performance, supplier approval, verification activities and corrective action. It is not satisfied simply by obtaining a certificate. Seafood, juice, low-acid canned food, dietary supplements and certain small-importer situations have specific regulatory treatment.

Food & Beverages Animal Food & Veterinary Products Dietary Supplements

Federal regulationFDA

Human Cells and Tissues: Part 1271 and Tissue Practices

21 CFR Part 1271; PHS Act sections 351 and 361

Part 1271 addresses human cells, tissues, and cellular and tissue-based products, or HCT/Ps. It establishes requirements concerning registration, donor eligibility, tissue practices and records. Regulatory treatment depends on the product and its intended use, including minimal manipulation and homologous use. Meeting registration requirements does not establish that a product qualifies for regulation solely under section 361 or has FDA marketing approval.

Pharmaceuticals & Biologics Medical Devices & Diagnostics

Federal regulationFDA

Human Food: Current Good Manufacturing Practice and Preventive Controls

21 CFR Part 117

Part 117 connects hygienic food production with a written, risk-based food safety system. Its preventive-controls provisions generally cover facilities required to register with FDA, while the applicability of current good manufacturing practice is not determined solely by registration. The regulation addresses hazard analysis, preventive controls, verification, supplier controls and records, with exemptions and modified requirements for specified operations.

Food & Beverages

Federal regulationFDA

In Vitro Diagnostic Products: Labels and Instructions

21 CFR Part 809, especially section 809.10

Part 809 establishes labeling provisions for in vitro diagnostic products for human use. Immediate-container labels and accompanying instructions serve different functions. Intended use, specimen requirements, procedure, limitations and performance information must correspond to the actual product. Research-use and investigational-use statements are conditional regulatory categories, not alternative labels that make a clinical diagnostic product exempt from premarket requirements.

Medical Devices & Diagnostics

Federal regulationFDA

Juice HACCP: Hazard Analysis and Pathogen Reduction

21 CFR Part 120

Part 120 establishes a juice-specific HACCP system, including written hazard analysis, sanitation controls, trained personnel and records. Its pathogen-reduction provisions contain important product and processing distinctions. Retail juice, shelf-stable products, thermally concentrated products and low-acid canned juice cannot be treated as interchangeable categories. FDA’s guidance explains hazards and the relationship with FSMA without creating a separate approval scheme.

Food & Beverages

Federal regulationFDA

Laser Products: Radiation Performance and Manufacturer Certification

21 CFR 1040.10 and 1040.11; related Parts 1002 and 1010

Laser products can be subject to federal radiation performance standards as well as records, reports and manufacturer-certification requirements. Product classification, accessible emissions, protective features, labeling and user information affect the analysis. Medical lasers also raise medical-device obligations. An FDA report accession number acknowledges a report; it is not product approval or a substitute for evidence supporting the manufacturer’s certification.

Radiation-Emitting Products Medical Devices & Diagnostics

Federal regulationFDA

Low-Acid Canned Foods: Thermal Processing and Container Integrity

21 CFR Part 113; 21 CFR 108.35

Part 113 addresses commercial processing of low-acid foods packaged in hermetically sealed containers. It connects scientifically established scheduled processes with retort or other processing systems, container closure integrity, critical factors and production records. Registration and process filing arise under Part 108. The framework concerns commercial sterility and process control, not a general nutritional or product-quality endorsement.

Food & Beverages

Federal regulationFDA

Medical Devices: 510(k) Premarket Notification

21 CFR Part 807, Subpart E; FD&C Act section 510(k)

The 510(k) pathway evaluates substantial equivalence to a legally marketed predicate device. Device classification, intended use, technological characteristics and exemption limitations determine whether the pathway is available and what evidence is needed. FDA clearance permits marketing under the reviewed conditions but is not the same regulatory decision as premarket approval. Establishment registration and device listing do not confer clearance.

Medical Devices & Diagnostics

Federal regulationFDA

Medical Devices: Quality Management System Regulation

21 CFR Part 820; ISO 13485:2016 incorporated by reference

The Quality Management System Regulation is the current FDA device CGMP framework, effective February 2, 2026. Part 820 incorporates ISO 13485:2016 by reference with FDA-specific provisions and definitions. Manufacturers must consider the complete regulatory framework rather than treating a third-party ISO certificate as an FDA approval. FDA also changed its device inspection approach when QMSR became effective.

Medical Devices & Diagnostics

Federal regulationFDA

Medical Devices: Unique Device Identification and GUDID

21 CFR Part 830; related labeling provisions in 21 CFR Part 801

The UDI framework links a device identifier on labels and packages with specified information submitted to FDA’s Global Unique Device Identification Database. The labeler has responsibilities that can differ from the legal manufacturer’s role. Device identifiers and production identifiers serve separate purposes. Exceptions, direct-marking requirements and applicable compliance policies must be assessed for the specific device rather than inferred from a barcode alone.

Medical Devices & Diagnostics

Statutory or administrative frameworkFDA

OTC Drugs: Monographs and Administrative Orders

FD&C Act section 505G; applicable OTC monograph administrative orders

The OTC monograph pathway permits qualifying nonprescription drugs to be marketed without an approved drug application when section 505G and other applicable requirements are met. Administrative orders establish or change the relevant conditions. The assessment concerns a therapeutic category, active ingredients, uses, doses, routes, labeling and testing, not simply whether a product is sold without a prescription.

Pharmaceuticals & Biologics Cosmetics & Personal Care

Federal regulationFDA

Produce Safety: Growing, Harvesting, Packing and Holding

21 CFR Part 112

Part 112 establishes minimum practices for covered produce during growing, harvesting, packing and holding. Its coverage depends on the commodity, activities and farm circumstances. Worker hygiene, agricultural water, biological soil amendments, animals, equipment and sprouts receive specific treatment. The amended pre-harvest agricultural-water provisions for non-sprout produce must be distinguished from harvest and post-harvest water requirements.

Food & Beverages Agriculture, Grading & Organic Products

Federal regulationFDA

Seafood HACCP: Fish and Fishery Products

21 CFR Part 123

Seafood HACCP addresses hazards associated with fish, handling and processing conditions. Covered processors conduct a hazard analysis and implement a HACCP plan when a food-safety hazard is reasonably likely to occur. Sanitation monitoring, trained personnel, verification, records and importer responsibilities accompany the plan. FDA’s fish-hazards guidance supports product-specific analysis but does not replace the regulation.

Food & Beverages