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FDA Guidance

July 29, 2016

Human Factor Considerations for Medical Device Manufacturers

Consideration of human factors when designing a medical device should be a high priority. It is important that concerns regarding human factors are considered during the development phase of new medical devices. For many years, this phase of the process...

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July 6, 2016

New US FDA Guidance on the Use of International Standard ISO 10993-1: Top 10 Changes

As anticipated, the United States Food and Drug Administration (US FDA) issued a new guidance document on the use of ISO 10993-1 on June 16, 2016. In one statement the FDA summarizes how they want to see biocompatibility for medical...

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June 16, 2016

FDA Releases ISO 10993-1 Guidance Document

FDA released the long-awaited guidance document for international standard ISO 10993-1 this week. The guidance document represents the current thinking of FDA on the topic of ISO 10993-1 “Biological evaluation of medical devices – Part I: Evaluation and testing within...

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May 24, 2016

Quick Guide to FDA’s Draft Guidance on 3D Printed Devices

Posted in Printing Services by MDDI Staff on May 24, 2016 A new leapfrog guidance from FDA gives a glimpse into the agency’s thinking on 3D printed medical devices. On May 10, 2016, FDA released a leapfrog guidance document on the...

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March 25, 2016

FDA Proposes Ban on Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Gloves

FDA is proposing to ban powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s gloves. The Agency determined that an unreasonable and substantial risk of illness or injury may occur from using these medical products and...

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