FDA Law Blog

JANUARY 6, 2022

220 and was described on HP&M’s blog here. Note that while EKRA was passed as part of a bill to combat the opioid crisis, its definition of “laboratory” applies to lab activities far beyond those involving opioid or other drug testing. In particular, the employee exemption, relevant to the S&G Labs Haw.,

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. Note that while EKRA was passed as part of a bill to combat the opioid crisis, its definition of “laboratory” applies to lab activities far beyond those involving opioid or other drug testing. In particular, the employee exemption, relevant to the S&G Labs Haw.,

Lab Testing 40

Lab Testing Referral Individual 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. The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions.

Clinic 52

Clinic Medical Provider Patients 52

FDA Law Blog

AUGUST 3, 2022

Mullen — Happy Birthday Laboratory Developed Tests (LDTs). Of course, FDA’s August 3, 1992 statement that it could regulate LDTs came long after laboratories began offering diagnostic tests. It came 16 years after Congress passed the Medical Device Amendments of 1976, without saying a word about FDA authority over laboratory testing.

Lab Testing 98

Lab Testing Government IT Manufacturing 98