FDA Law Blog

DECEMBER 12, 2022

If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s an easy yes that you are a manufacturer of a medical device. or other similar or related article” which is “intended for use in the diagnosis of disease or other conditions.”

Medical 23

Medical Manufacturing Electronics Provider 23

CDOCS

MAY 4, 2021

Without this additional skill set and post graduate training I simply could not deliver the results that my patients deserve. We need to recognize how clinical dentistry has become intertwined with digital technologies to synergistically assist us in providing enhanced diagnosis with safe and predictable treatment outcomes. &

Patient-Centered 52

Patient-Centered Patients Manufacturing Provider 52

CDOCS

JUNE 30, 2021

Specifically, the patient stated he wanted younger-looking teeth and was tired of having the composites replaced every few years, and therefore desired an esthetic and lasting solution. Furthermore, upon clinical examination and evaluation of radiographs, a diagnosis of recurrent decay was established on teeth #s 6 through 11.</span></p>

Family 40

Family Families Patients Manufacturing 40

FDA Law Blog

OCTOBER 14, 2024

At the clinics, Defendants offer treatments that consist of extracting fat tissue from patients and, through a multi-step process, turning that tissue into a liquefied mixture of stem cells, other cells and cell debris known as Stromal Vascular Fraction (SVF). 21 U.S.C. §

Clinic 59

Clinic Patient-Centered Asthma Patients 59

GeriPal

JUNE 20, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

IT 120

IT Patient-Centered Patients Clinic 120

FDA Law Blog

JANUARY 26, 2022

Speaking from a bit of experience, this has led to countless field direction memos instructing sales reps on how to pivot from their opening disease awareness presentations to their product details in an effort to keep these two types of communications separate. Creating TV commercials ain’t cheap nor is the air time for them.

IT 40

IT Education Utilities Patient-Centered 40

FDA Law Blog

OCTOBER 17, 2023

If you are developing such products, now may be the time to explore the opportunities presented by the Breakthrough Devices Program. FDA recognizes the existence of barriers that may hinder underserved populations from receiving medical treatment or diagnosis.

Medical 53

Medical Diagnosis Healthcare Clinic 53