FDA Law Blog

JANUARY 6, 2022

220 and was described on HP&M’s blog here. S&G Labs Hawaii, LLC (“S&G Labs”) is a Hawaiian laboratory company that performs various lab testing services including toxicology (for both legal and illicit substances) and COVID testing. S&G Labs Haw., EKRA is codified at 18 U.S.C. §

Lab Testing 52

Lab Testing Referral Individual Patient-Centered 52

FDA Law Blog

JANUARY 6, 2022

220 and was described on HP&M’s blog here. S&G Labs Hawaii, LLC (“S&G Labs”) is a Hawaiian laboratory company that performs various lab testing services including toxicology (for both legal and illicit substances) and COVID testing. S&G Labs Haw., EKRA is codified at 18 U.S.C. §

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

FDA Law Blog

OCTOBER 10, 2022

You can find our preliminary blog post on the release of this guidance here , and our blog posts on the draft CDS guidances here and here. Specifically, the guidance interprets the Cures Act’s four criteria for exclusion of CDS software functions from FDA’s medical device jurisdiction (so-called “Non-Device CDS”).

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Clinic Medical Provider Patients 52

FDA Law Blog

AUGUST 3, 2022

It came 16 years after Congress passed the Medical Device Amendments of 1976, without saying a word about FDA authority over laboratory testing. And it came four years after the comprehensive federal legislation governing laboratories, again without mentioning FDA or referring to such tests as devices. On the other side, Sen.

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Lab Testing Government IT Manufacturing 98