Blog Electronics Provider Screening 
The Health Policy Exchange
SEPTEMBER 2, 2020
Our residency, formerly a collaboration with Providence Hospital, is now known as the Medstar Health/Georgetown-Washington Hospital Center Family Medicine Residency Program. MDPCP promises to narrow the primary care-subspecialist reimbursement gap and provide opportunities to improve patient care in the short term. Phillips, Jr.
Dr. Zaar
MAY 20, 2025
Today, virtual care provides quick, convenient access to expert endocrinologists. In this blog, we’ll answer the most common questions and explain why more people are choosing online hormonal therapy services across Canada. If you do not have coverage, many online platforms provide inexpensive self-pay options.
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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. The submitter would select “Additional Information” in eSTAR and see a pop up that provides information on next steps. add-to-files).
FDA Law Blog
NOVEMBER 20, 2024
The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting. FDA is extending the comment period on the notice published September 20, 2024 ( 89 FR 77162 ).
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 On September 29, 2023, FDA released a draft guidance on Electronic Submission Template for Medical Device De Novo Requests.
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). Once your request for an in-person or hybrid meeting is agreed upon, you are expected to provide a list of in-person and virtual attendees.
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.
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