Blog | Regulatory + Quality Assurance | Michelle Lott

We led an effort to overturn an FDA rule to down-classify 91 devices to Class 1 or 2 and make them 510(k) exempt....

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Why do we need a document control process? Oh, if only I had a nickel for every time I’ve been […]...

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How do you determine the correct FDA submission for combination products? What IS a combination product? A combination p...

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Very few days go by without someone asking me to explain the differences between FDA submission types. This most often [...

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If you think that getting a medical device onto market is a long and tedious process, be glad you don’t […]...

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Just over a year after COVID-19 put the world on hold, the powers that be have released a news brief […]...

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