Exhaustive Extractions

At iuvo, we work hard to stay on the cutting edge of new developments in testing and regulatory changes affecting the medical device and pharmaceutical industries. We will share these updates regularly here in our blog - Exhaustive Extractions.

FDA Issues Guidance Document on 3D Printed Devices

On December 5, 2017, the FDA issued the final version of its guidance document for 3D printed devices.  The document "Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff" is meant to outline the agency's current thinking about devices made via these processes and will be supplemented by a webinar in January.  More information on the webinar is available here.  

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FDA Issues New Guidance Documents, Notable Changes to Pre-Submission Process

The FDA has issued a number of guidance documents, primarily focused on the pre-submission process that medical device manufacturers use to improve the likelihood of success of a particular filing. 

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