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Tag Archives: FDA

Share on Google+ June 27, 2017

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FDA changes that are now in effect.

Category : FDA, Regulatory

The Food and Drug Administration (FDA) is amending regulations to reflect changes recently enacted into law by the 21st Century Cures Act. Specifically, certain requirements related to humanitarian device exemptions (HDEs) and institutional review boards (IRBs) for devices have changed. This action is being taken to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act)

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Share on Google+ May 8, 2017

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An Update From The APS In-Vitro Testing Laboratory

Category : APS Service Offerings, FDA, GLP, In-vitro testing, Our Laboratories

The In-vitro Testing Laboratory has had a busy start to 2017. Most recently, we presented at the Society of Toxicology (SOT) conference on the improvements of the multiple hemocompatibility tests, including the In-vitro Blood Loop Assay and Platelet/Leukocyte Count Assay. Collaboration with the FDA is ongoing for the In-vitro Blood Loop assay – we have submitted our methods and protocol

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Share on Google+ April 3, 2017

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FDA CDRH Experiential Learning Program is open for comments

Category : FDA, Medical Device testing

The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced on March 23, 2017 that the submission period for Experiential Learning Program (ELP) in open. ELP is a training component intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, patient perspective/input, quality system management, and other challenges that impact the device

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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 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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Share on Google+ May 12, 2015

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Withdrawal of 47 FDA Draft Guidance Documents

Category : FDA

On May 6th, 2015, the FDA announced it would withdrawal 47 draft guidance documents published before December 31, 2013. The FDA has stated that “In recent years, FDA’s guidance workload has increased due to requests from the public for guidance to clarify specific issues and statutorily mandated guidances. Many of these draft guidances were not finalized most often because of

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