Overview of Device Regulation | FDA
Jan 31, 2024 · Overview of regulations for medical devices: premarket notifications (510 (k)), establishment registration, device listing, quality systems, labeling and reporting requirements.
eCFR :: 21 CFR Chapter I Subchapter H -- Medical Devices
Learn more about the eCFR, its status, and the editorial process.
Jan 4, 2023 · Under its authorities in the Federal Food, Drug, and Cosmetic Act (FFDCA), FDA regulates the safety and effectiveness of medical devices, which are a type of medical product.
The U.S. FDA Regulatory Landscape for Medical Devices
Nov 24, 2025 · Learn how U.S. FDA regulations shape the medical device market. This expert guide explains device classification, global industry trends, regulatory pathways, and …
Code of Federal Regulations (CFR) | FDA
Most of FDA's medical device and radiation-emitting product regulations are in Title 21 CFR Parts 800-1299. These final regulations codified in the CFR cover various aspects of design, clinical...
Facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer …
Medical Devices; Quality Management System Regulation …
2 days ago · The Food and Drug Administration (FDA, the Agency, or we) is amending certain medical device regulations to revise references and language in existing Code of Federal …
eCFR :: 21 CFR Part 820 -- Quality System Regulation
The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the …
Updated May 26, 2023 Medical Product Regulation: Drugs, Biologics, and Devices The Food and Drug Administration (FDA) regulates the safety and effectiveness of drugs, biologics, and …
Learning Objectives Explain FDA’s role in regulating medical devices Define a medical device and review basics about device classification Describe five steps to get a new product to...