FDA Archives - In Compliance Magazine

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 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...

FDA Issues Draft Guidance on 510(k) Electronic Submission Template

The U.S. Food and Drug Administration (FDA) has issued a draft guidance to further support its efforts to facilitate the online submission of 510(k) review requests. The draft guidance, “Electronic Submissio... Read More...

FDA Publishes List of Approved AI/ML-Enabled Medical Devices

The U.S. Food and Drug Administration (FDA) has published its first list of authorized medical devices incorporating software based on artificial intelligence (AI) and machine learning (ML) technologies. Pos... Read More...

FDA Offers Online Tracker for Premarket Submissions

The U.S. Food and Drug Administration (FDA) now has a secure web-based tracking system to help companies track the progress of the agency’s review of their 510(k) submissions. The FDA’s Premarket Submission’... Read More...

FDA Releases Discussion Paper on Medical Device Cybersecurity Challenges

The U.S. Food and Drug Administration (FDA) has released a discussion paper on specific cybersecurity practices related to the servicing of medical devices. The discussion paper, “Strengthening Cybersecurity... Read More...

FDA Extends Comment Period on Remanufacturing of Medical Devices Guidance

The U.S. Food and Drug Administration (FDA) has extended the public comment period on its recently issued draft guidance on the remanufacturing and servicing of medical devices. According to a Notice published... Read More...