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Tag Archives: regulatory

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+ 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+ January 23, 2017

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The APS Preclinical Program: Your Path to Success in 2017

Category : Our Laboratories

Finding a reliable partner in the preclinical CRO space can be challenging. In the early stages of product development, having a partner you can trust and rely on is of paramount importance. Welcome to American Preclinical Services. APS is an AAALAC and ISO17025 accredited, USDA registered and GLP compliant preclinical center of excellence located in Minneapolis, MN. At APS, we

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