fda Archives - In Compliance Magazine

FDA Issues Final Guidance on ISO 10993-1 for Biological Evaluation of Medical Devices

The U.S. Food and Drug Administration (FDA) has issued a final guidance document on the use of ISO 10993-1 in the assessment of medical devices that come in direct or indirect contact with the human body. IS... Read More...

FDA Issues Draft Guidances on Clinical Data, Predicate Devices in Premarket Notifications

The U.S. Food and Drug Administration (FDA) has recently issued two draft guidance documents that may be of interest to medical device developers and manufacturers. Issued in early September, the first draft... Read More...

FDA Issues Warning About Ultraviolet Wands

The U.S. Food and Drug Administration (FDA) has issued a warning to consumers about potential risks associated with the use of certain brands of ultraviolet (UV) wands promoted to disinfect surfaces. UV wand... Read More...

FDA Updates List of Recognized Standards

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...

FDA Issues Guidance on Qualification of Medical Device Development Tools

The U.S. Food and Drug Administration (FDA) has published its final Guidance on the qualification of tools for evaluating medical devices. Published in mid-July, the Guidance, “Qualification of Medical Devic... Read More...

FDA Announces eMDR Enhancements

The U.S. Food and Drug Administration (FDA) has posted a list of pending enhancements to its online electronic medical device reporting system (also known as eMDR). In an update to its website, the FDA ident... Read More...

FDA Releases Final Guidance on Pre-Market Submissions for Med Device Software Functions

The U.S. Food and Drug Administration (FDA) has published a final version of its Guidance on the recommended documentation on software functions in medical devices to be included in premarket submissions for FD... Read More...

FDA Releases New Video on Cybersecurity in Healthcare Facilities

As part of its effort to protect healthcare workers and patients from equipment malfunction attributable to cybersecurity breaches, the U.S. Food and Drug Administration (FDA) has released a new video to help h... Read More...

FDA Updates Consumer Information on OTC Hearing Aids

In a separate development, the U.S. Food and Drug Administration (FDA) has also updated its information webpage for consumers on over-the-counter (OTC) hearing aids. Authorized by the FDA for sale in October... Read More...

FDA Releases Latest Third-Party Review Performance Report

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. ... Read More...

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