FDA Law Blog

JANUARY 6, 2022

220 and was described on HP&M’s blog here. Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.”

Lab Testing 52

Lab Testing Referral Individual Patient-Centered 52

FDA Law Blog

OCTOBER 10, 2022

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. 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”).

Clinic 52

Clinic Medical Provider Patients 52

FDA Law Blog

JANUARY 6, 2022

220 and was described on HP&M’s blog here. Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.”

Lab Testing 40

Lab Testing Referral Individual Patient-Centered 40

FDA Law Blog

AUGUST 3, 2022

These products are subject to the same regulatory requirements as any unapproved medical device”). Of course, FDA’s August 3, 1992 statement that it could regulate LDTs came long after laboratories began offering diagnostic tests. As we began to prepare this blog, we thought it might be both birthday card and death notice for LDTs.

Lab Testing 98

Lab Testing Government IT Manufacturing 98