Blog & Insights

Did You Know – Q1 2023

DID YOU KNOW? Facet only works with smaller life sciences companies, academic institutions, or nonprofit organizations to help get their products to and through FDA Facet was regulatory lead for two US marketing approvals in 2...

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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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