fda Archives - Page 4 of 17 - In Compliance Magazine

FDA Warns of Medical Device Cyber Vulnerabilities

The U.S. Food and Drug Administration (FDA) has issued an alert to medical device manufacturers and users regarding a cybersecurity vulnerability identified in connection with a widely used web-based software t... Read More...

FDA Releases Final Guidance on Voluntary Recalls

The U.S. Food and Drug Administration (FDA) has issued a final guidance to help medical device manufacturers and others facilitate the execution of voluntary product recalls. The guidance, “Initiation of Vol... Read More...

FDA to Amend Medical Device Quality System Regulation

The U.S. Food and Drug Administration (FDA) has requested public comment on its plan to harmonize its current good manufacturing practice requirements applicable to medical device quality systems with internati... Read More...

FDA Updates 510(k) Third-Party Performance Metrics

The U.S. Food and Drug Administration (FDA) has published its most recent data on the performance of accredited third parties conducting primary reviews of medical devices under the Agency’s 510(k) process. Th... Read More...

FDA Publishes Discussion Paper on 3D Printing of Medical Devices

The U.S. Food and Drug Administration (FDA) has released a discussion paper on the use of so-called 3D printing technology in the production of medical devices in hospitals and doctors’ offices. The paper, “... Read More...

FDA Updates List of Recognized Standards for Medical Devices

The U.S. Food and Drug Administration (FDA) has updated its list of recognized international and national standards that can be used to demonstrate compliance with certain requirements for premarket review and ... Read More...

ANSI HAC Standard Now Recognized by the FDA and FCC

In some good news for those with impaired hearing, the U.S. Food and Drug Administration (FDA) has now recognized the updated version of an important industry standard. In its latest revised list of recogniz... Read More...

FDA Publishes Principles for AI and ML in Medical Devices

Medical device regulatory agencies in the U.S., Canada, and the United Kingdom have recently released a document outlining “guiding principles” essential to the development of medical devices using artificial i... Read More...

FDA Takes Steps to Ease Access to OTC Hearing Aid Devices

The U.S. Food and Drug Administration (FDA) is taking action to ease public access to over-the-counter (OTC) hearing aids and other personal sound amplification devices. In a Proposed Rule published in the Fed... Read More...

FDA Offers Best Practices for Alerting About Cyberthreats

As concerns about cybersecurity become part of the everyday threat landscape, the U.S. Food and Drug Administration (FDA) is taking steps to help medical device manufacturers educate consumers about cybersecuri... Read More...

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