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District Court Interprets EKRA

FDA Law Blog

220 and was described on HP&M’s blog here. C) the amount billed to or received from, in part or in whole, the health care benefit program from the individuals referred to a particular recovery home, clinical treatment facility, or laboratory. S&G Labs Haw., EKRA is codified at 18 U.S.C. § 18 U.S.C. § 18 U.S.C. §

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District Court Interprets EKRA

FDA Law Blog

220 and was described on HP&M’s blog here. C) the amount billed to or received from, in part or in whole, the health care benefit program from the individuals referred to a particular recovery home, clinical treatment facility, or laboratory. S&G Labs Haw., EKRA is codified at 18 U.S.C. § 18 U.S.C. § 18 U.S.C. §

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The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Law Blog

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. While the final guidance continues to borrow some IMDRF concepts, it no longer limits Non-Device CDS to software that informs clinical management (per the IMDRF guidelines).

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