medical devices Archives - In Compliance Magazine

MedTech Europe Offers Its Vision for the Future of MedTech Regulations

A consortium of medical technology companies in the European Union (EU) has published a document outlining its vision for the future of the EU’s medical technology regulations. In its position paper, titled ... Read More...

FDA Issues Guidance on Electronic Submissions of 510(k)s

The U.S. Food and Drug Administration (FDA) has released its final guidance on premarket notification (510(k)) submissions by electronic format. Published in early October, the Guidance, “Electronic Submissi... Read More...

FDA Issues Final Guidance on Testing/Labeling of Medical Devices in MR Environments

The U.S. Food and Drug Administration (FDA) has released the final version of its Guidance on ensuring the safety of medical devices used in proximity to magnetic resonance imaging (MRI) equipment. Published... Read More...

FDA Issues Guidance on Medical Device Cybersecurity Quality System Considerations

The U.S. Food and Drug Administration (FDA) has released its Final Guidance on cybersecurity considerations for medical devices to assist device manufacturers in preparing premarket submissions. Released in ... Read More...

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The U.S. Food and Drug Administration (FDA) has recently issued two draft guidance documents that may be of interest to medical device developers and manufacturers.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 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...

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