The Health Policy Exchange

SEPTEMBER 2, 2020

Health Policy Fellowship three years ago, though I still enjoy working alongside these talented family physicians in clinic, such as Dr. Brian Antono, who recently blogged about his fellowship experiences for Harvard Medical School's Center for Primary Care. Phillips, Jr.

Primary Care 130

Primary Care Primary Care Physician Patient-Centered Behavioral Health Services 130

FDA Law Blog

OCTOBER 5, 2022

The development of an electronic submission template for 510(k) submissions is significant in that: eSTAR submissions are not expected to go through the refuse to accept (RTA) process. Exemptions from the electronic submission requirements apply to interactive review responses and some amendments (e.g., add-to-files).

Electronics 45

Electronics Medical Screening IT 45

Dr. Zaar

MAY 20, 2025

In this blog, we’ll answer the most common questions and explain why more people are choosing online hormonal therapy services across Canada. You will get hold of prescriptions electronically, and And observe-up visits manifest thru video or smartphone calls. What Is Hormonal Therapy?

Consulting 52

Consulting Insurance Appointment Telemedicine 52

FDA Law Blog

OCTOBER 24, 2023

Mullen — As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted to FDA using the electronic Submission Template And Resource ( eSTAR ). On September 29, 2023, FDA released a draft guidance on Electronic Submission Template for Medical Device De Novo Requests.

Medical 52

Medical Electronics Provider Screening 52

FDA Law Blog

SEPTEMBER 17, 2023

For example, device sponsors can request a meeting with an FDA review team by submitting a pre-submission to CDRH (see our recent blog on the minor updates to the Pre-Submission Guidance). If you are driving, stop at the vehicle screening facility and inform security that you are attending a meeting.

Screening 59

Screening Transportation Provider Electronics 59

Physician's Practice

JUNE 19, 2025

Reynolds Fact checked by Chris Mazzolini Blog Article These essential strategies will enable your practice to safeguard digital assets and ensure compliance. Even innocuous habits— scrolling social media at the nurses’ station —can expose screens to wandering eyes or distract staff from patient care.

Management 52

Management Patients Screening Finance 52

FDA Law Blog

JULY 10, 2023

In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. FDA Day (in calendar days) FDA Actions Day 1 FDA receives 510(k) submission.

Provider 75

Provider IT Engineering Medical 75