Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional.
Below is
Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, the Senate Finance Committee discussed making permanent COVID-19 flexibilities, including those related to telehealth. See the hearing and other news below.
I.Regulations, Notices & Guidance
On May 19, 2021, the Food and Drug Administration (FDA) issued draft guidance entitled,
Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus. The draft guidance provides recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with Type 2 Diabetes Mellitus. These medical de