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Monthly Archives: March 2017

Share on Google+ March 29, 2017

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FDA Regenerative Medicine Advanced Therapy (RMAT) Designation is now live

Category : FDA

FDA Regenerative Medicine Advanced Therapy (RMAT) Designation is now live. Regenerative medicine encompasses a wide scope of innovative products including: cell therapies e.g., chimeric antigen receptor T-cells (CAR-T cells) and human tissues grown on scaffolds therapeutic tissue engineering products human cell and tissue products certain combination products using such therapies Recognizing the importance of Regenerative Medicine, Congress included several provisions

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Share on Google+ March 27, 2017

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Introducing the New APS FlightLog Portal: Performing Biocompatibility Just Got Easier!

Category : APS Service Offerings, Our Laboratories

Did you know that APS provides ISO 10993 biocompatibility testing for the medical device and biotechnology industry?  We have developed a unique process for biocompatibility test panel creation, sample submission, and study reporting via our online APS FlightLog Portal. Recently this system has been improved by adding an integrated dashboard and optimizing the user interface. Two-step submission process: This feature was put in place

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Share on Google+ March 21, 2017

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FDA proposes to exempt more than 300 devices from 510(k) Requirements

Category : FDA, Medical Device testing

On 14 March 2017, FDA proposed to exempt more than 300 devices from 510(k) Requirements. Key Points: US FDA has proposed exempting nearly 340 Class II medical devices from 510(k) requirements. The exemptions are part of the 21st Century Cures Act, passed on December 13th, 2016. Newly exempt devices will still need to meet other FDA regulations such as 21

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