Blogs

Spotlight On – Q1 2023

RECENT FACET SUCCESSES – JUST A FEW HIGHLIGHTS INDUSTRY FIRST FOR MEDICAL DEVICES:   Facet is the first organization to work with the FDA and a medical device Sponsor to prepare and submit a combination product 510(k) usi...

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Are You a Drug or Device?

Are You a Drug or Device?Unseen Regulatory and Intellectual Property Impact of Genus Regulatory history was made on 9 August 2021 in a Federal Register notice (Docket No: FDA-2021-N-0843) announcing that in accordance with the ...

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