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 Delays Implementation of Changes to "Intended Use"

On January 16, 2018, the FDA announced that the Agency will be delaying implementation of parts of its "intended use" rule due to concerns raised by the industry.

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Recent FDA Announcements - Accessories and Least Burdensome Provisions

There's frequently a flurry of FDA announcement near the end of the year, and this year was no exception.  We wanted to highlight a couple of the more pertinent ones that may be of interest to our customers.  The summaries below link to some of the more interesting guidance documents recently released.

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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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FDA Updates Guidance on Exempt Class II Devices

On July 11, 2017, the US FDA published a final list of Class II devices exempt from 510(k) Premarket Notification Requirements (82 FR 31976).  As mentioned previously here, in an effort to comply with the 21st Century Cures Act of 2016, the Agency originally issued a notice on March 14, 2017 in the Federal Register proposing to exempt a list of Class II devices from the 510(k) premarket notification requirements, with certain limitation (82 FR 13609).  

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