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FDA

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Quick Guide to FDA’s Draft Guidance on 3D Printed Devices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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May 19, 2016

Endoscope Sampling Kit Now Available

With their flexibility and complex components, endoscopes present unique cleaning and disinfecting challenges. Endoscope manufacturers, regulatory bodies, and healthcare facilities are increasingly concerned about the spread of communicable diseases, including clinically relevant microorganisms, on reprocessed medical devices. The concern over...

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March 23, 2016

Updated Pyrogenicity Considerations for New Medical Devices

Effective March 21, 2016, FDA released updates to the guidance Submission and Review of Sterility Information in Premarket Notification (501(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff. Specifically, the document addresses an...

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March 10, 2016

Nelson Labs Experts Invited to Present at Joint Conference

Thor Rollins, consulting manager, and Audrey Turley, research scientist, have been invited to speak at the joint conference of the Association of Analytical Communities Southern California Section (AOAC SCS) and Food and Drug Agency (FDA) 2016 Spring Conference. Rollins and...

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September 9, 2015

Improving Medical Device Approval Timelines

The business of getting medical devices to market is a complex web of variables including the laboratory testing we do at Nelson Labs. We know that an intimate knowledge of regulatory behavior, draft guidance and guidance documents can significantly improve...

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