Welcome Dr. Ruffo
OCFM
OCTOBER 23, 2020
October 23, 2020 / Jack Forbush, DO / News Jack Forbush, DO Helpful video out together by one. Notice of Privacy Policy
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FDA Releases Final Guidance on Use of Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
FDA Law Blog
FEBRUARY 9, 2024
We previously blogged on the draft guidance ( here ) and on FDA’s broader framework for Digital Health Technologies (DHT) ( here and here ). A DHT is a system that uses computing platforms, connectivity, software, and/or sensors, for health care and related uses.
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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach
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.
OTAT Becomes the Office of Therapeutic Products (OTP) and Kicks off Town Hall Series – They appear to be tired of writing the same “Complete Response” Letters
FDA Law Blog
OCTOBER 6, 2022
The standard practice is for FDA to engage with companies on an individual basis through formal meetings and deliver directed feedback to specific sponsor questions. OTP has spent years communicating industry-wide problems on an individual basis. OTP recognized that this strategy may not be possible for all products (e.g.,
Anatomy of a Healthy Plate- Guest Blogger Rebecca Gray
New South Family Medicine and MedSpa
SEPTEMBER 17, 2019
However, people need to understand what works best for them individually. blog":{"type":"Static","pageId":"tomo1"},"./medspa-policies":{"type":"Static","pageId":"c8gi2"},"./event-list":{"type":"Static","pageId":"lmi71"},"./general-clean":{"type":"Static","pageId":"u6anc"},". Food has the power to regenerate the new you!
Do You Hear What I Hear? One Year of OTC Hearing Aids
FDA Law Blog
NOVEMBER 8, 2023
The rule established a new category of OTC hearing aids for individuals with mild to moderate hearing loss, allowing them to purchase hearing aids directly from stores or online retailers without the need for a medical examination, prescription, or fitting adjustment by an audiologist. In some measurable ways, the rule has been a success.
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