Jan 31, 2024 · Overview of regulations for medical devices: premarket notifications (510 (k)), establishment registration, device listing, quality systems, labeling and reporting requirements.

May 5, 2017 · However, a fundamental revision of those Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices …

Dec 4, 2025 · SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is amending certain medical device regulations to revise references and language in existing …

Learn more about the eCFR, its status, and the editorial process.

Jan 4, 2023 · Medical device manufacturers are subject to a range of regulatory controls (i.e., requirements) to ensure that devices are not adulterated or misbranded and to otherwise …

Apr 17, 2025 · In the United States, Congress has granted the FDA significant but defined authority to test, monitor, and classify medical devices, subject to statutory requirements and …

Assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Provide consumers, patients, …

In the U.S., FDA regulates the sale of medical device products. Before a medical device can be legally sold in the U.S., the person or company that wants to sell the device must seek...

Jan 21, 2025 · Medical Device Reporting (MDR), governed by 21 CFR Part 803, establishes essential requirements for manufacturers, importers, and user facilities to be promptly …

Dec 11, 2024 · Whether you’re new to the industry or looking for a better way to navigate compliance, this guide will walk you through the essential medical device standards and how …