An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: Regulatory Information

Regulatory Information

Search for FDA guidance documents, learn about the laws enforced by FDA, and more.

Topic Paragraphs

An FDA shellfish specialist (left) and a New Jersey state inspector look at a map of the waters where the clams in the foreground were harvested.

Search for FDA Guidance Documents

Search for official FDA guidance documents and other regulatory guidance for all topics.

Rules & Regulations

Summary of the FDA's process for rulemaking.

Laws Enforced by FDA

The Federal Food, Drug, and Cosmetic Act and other congressional milestones are presented in this section.

Standards

FDA participates in the development of standards and uses standards to fulfill its regulatory responsibilities.

Freedom of Information

Electronic reading rooms contain publicly releasable agency records and other information routinely made available.

Dockets Management

Dockets management serves as the official repository for the administrative proceedings and rule-making documents for FDA.

gavel on top of books

Food and Drug Administration Safety and Innovation Act

FDASIA gives FDA the authority to collect user fees and fund review of innovator drugs, medical devices, generic drugs and biosimilar products.

hands typing on a computer keyboard

How to Make a FOIA Request

Guidelines for making a Freedom of Information Act request for public information.

balanced scales

Federal Food, Drug, and Cosmetic Act

Online access to the FDA's principal authorizing legislation.

FDA Forms

What does FDA regulate?

Comment on Proposed Regulations and Submit Petitions

Unified Agenda-TRACK: Upcoming FDA regulations

International Council for Harmonisation (ICH) Guidance Documents

Veterinary International Conference on Harmonization (VICH) Guidance Documents

Advisory Committee Guidance Documents

Clinical Investigators - Disqualification Proceedings

Approvals of FDA-Regulated Products

About FDA Product Approval

Nov 22

Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions

Medical Devices

Nov 22

Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway

Medical Devices

Nov 21

510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review

Medical Devices

FDA Guidance Search

Top