FDA Law Blog

OCTOBER 16, 2023

Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. The third article—“Your Medical Devices are Getting Smarter. Javitt & Steven J. The first article—“Is the Eye the Window to Alzheimer’s?”

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Vascular Physician

JUNE 26, 2022

If you've been diagnosed with a DVT (deep vein thrombosis), you may be wondering if your condition will resolve on its own or if medical intervention is necessary. If you've been diagnosed with a DVT (deep vein thrombosis), you may be wondering if your condition will resolve on its own or if medical intervention is necessary.

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Sound Physicians

OCTOBER 30, 2024

Osman Saleem Osman Saleem, MD Medical Director, Mercy Hospital of Buffalo We’re honored to host, and even launch, the careers of so many incredible healthcare professionals who are not only experts in their field but also dedicated to the health and vitality of their community. I appreciated the fact that there was always a fallback plan.

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Common Sense Family Doctor

JUNE 8, 2025

However, as stated plainly in a recent editorial published in more than 120 medical journals worldwide , “This does not mean humanity is any safer.” After peaking at more than 70,000 in 1986, the absolute number of weapons gradually declined from the implementation of various arms control treaties to 12,331 today.

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Noreta Family Medicine

MARCH 26, 2025

You Know DPC is working when… I decided to do something a little different in this blog. I’ve written blogs that discuss my perspective on why Direct Primary Care (DPC) is helpful to both patients and physicians in Columbia, SC (and beyond!). At Noreta, we provide care that considers patients’ health and finances.

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Sound Physicians

NOVEMBER 19, 2024

Fostering leadership potential While not every clinician aspires to be a leader , it ’ s crucial to provide avenues for those who do. Emerging Leaders Dr. Charles Charman, medical director and overseer of the Emerging Leaders program, presents at the 2024 EmLe cohort session at MDS. Enter the associate medical director.

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Louisville Lectures

MAY 5, 2023

Are you a resident or medical student looking to learn practical, evidence based approaches to your patients? We believe in the concept of Free Open Access Medical Education ( #FOAMed ) and we focus on internal medicine ( #FOAMIM ). These lectures will be provided by the University of Louisville Internal Medicine residents.

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Sound Physicians

MARCH 12, 2025

Increasingly a valuable option for rural hospitals, tele-ICU provides access to higher acuity care and support to emergency and hospital medicine clinicians who are called to the ICU. In many cases, patients who receive tele-critical care can stay in the community where they live and have a support network.

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Vascular Physician

DECEMBER 21, 2022

Taking medications: Diuretics, angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, and other medications may help manage your blood pressure as well as other conditions contributing to RAS, such as atherosclerosis. Renal Artery Stenosis: Is It Common & Life Threatening?

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East Cary Family Physicians

FEBRUARY 27, 2024

Insights from East Cary Family Physicians In this blog, we’re diving into one of the most prevalent health conditions worldwide: diabetes. Whether you’re newly diagnosed, caring for someone with diabetes, or seeking to enhance your knowledge, this guide aims to provide valuable insights and practical tips. What is Diabetes?

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FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). By McKenzie E.

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Sound Physicians

NOVEMBER 5, 2024

For hospitals, this means investing in cutting-edge medical interventions and partnerships that help them transition to the modern best-practice of dedicated ICU management. Sound also supports residency programs, which guarantee a consistent pool of new critical care clinicians who can provide support in the ICU.

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PEMBlog

MARCH 21, 2024

Be sure to check out our previous posts on: BRONCHIOLITIS , EPIGLOTTITIS , and PNEUMONIA The Problem: Free open access medical education (aka FOAM) is great in that it allows for asynchronous, focused learning. For each blog, we extracted information such as author names and date of publication. How can I use these findings?

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PEMBlog

MARCH 20, 2024

Be sure to check out our previous posts on: BRONCHIOLITIS and EPIGLOTTITIS The Problem: Free open access medical education (aka FOAM) is great in that it allows for asynchronous, focused learning. For each blog, we extracted information such as author names and date of publication. How can I use these findings? Happy learning!

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East Cary Family Physicians

JULY 26, 2023

In this blog, we will explore the significance of regular health check-ups and how they contribute to your overall well-being. Regular health check-ups are proactive visits to your healthcare provider when you are not experiencing any specific symptoms or ailments. What are Regular Health Check-ups?

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FDA Law Blog

MARCH 7, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development. DMC charters have also grown longer and more detailed. They also both stressed the value of previous DMC experience.

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East Cary Family Physicians

NOVEMBER 10, 2023

In this blog, we’ll delve into the basics of prostate cancer, from understanding the risks to exploring preventive strategies. Know Your Risk: Understanding your family history and risk factors can help you and your healthcare provider make informed decisions about screening and prevention.

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FDA Law Blog

JANUARY 30, 2025

Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance). This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials. Tobolowsky & Charles G. Raver & James E.

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FDA Law Blog

MAY 6, 2024

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. are cybersecure.

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FDA Law Blog

APRIL 2, 2024

There are a significant number of additional initiatives the Agency requests with sections dedicated to “Enhancing Data, Information, and Postmarket Safety;” “Addressing Medical Product Shortages and Supply Resiliency;” “Modernizing Foods Authority;” and “Other.”

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Minnesota Academy of Family Physicians

FEBRUARY 20, 2025

A Collaborative Approach Between Health Care Providers and Community Partners Food insecurity affects thousands of Minnesotans, often contributing to chronic health conditions and overall poor health outcomes. M Health Fairview’s Fair Table program ensures convenient access to food during medical appointments.

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Rao Doctor

APRIL 17, 2025

I was just browsing through some articles on a medical website-Medscape- and I came across a very interesting podcast on how to improve our health and vitality by eating sprouts. When sprouted, these grains become more nutritious and digestible, providing essential amino acids and B vitamins.

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FDA Law Blog

MARCH 31, 2025

That Rule sought to codify FDAs view that LDTs are medical devices subject to FDA regulation under the Food, Drug, and Cosmetic Act (FDCA) and then phase out, over a four-year period, FDAs purported policy of enforcement discretion for such tests. Gonzalez On March 31, 2025, U.S. District Judge Sean D.

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Sound Physicians

JUNE 25, 2025

Posted in Uncategorized Share Article Subscribe to the Sound Physicians Blog A trusted source for todays healthcare needs. Posted in Uncategorized Share Article Subscribe to the Sound Physicians Blog A trusted source for todays healthcare needs. Do you feel ready to make that move? All rights reserved.

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PEMBlog

MARCH 19, 2024

Be sure to check out our previous post on: BRONCHIOLITIS The Problem: Free open access medical education (aka FOAM) is great in that it allows for asynchronous, focused learning. For each blog, we extracted information such as author names and date of publication. How can I use these findings? Happy learning!

Education 52

Education Utilities Provider IT 52

FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. Data from chemical characterization studies must be evaluated in a separate TRA following ISO 10993-17 guidelines.

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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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PEMBlog

MARCH 18, 2024

The Problem: Free open access medical education (aka FOAM) is great in that it allows for asynchronous, focused learning. After searching 177 keywords using FOAMSearch, the top 50 FOAM websites on the (now defunct) Social Media Index, and seven additional PEM-focused blogs, we reviewed and quality assessed 441 blog posts on relevant topics.

Education 52

Education Utilities Community Management 52

ABIM

MAY 7, 2025

Specialties are each on their own review cycle, and several—including Advanced Heart Failure and Transplant Cardiology, Critical Care Medicine, Gastroenterology, Medical Oncology and Transplant Hepatology—are currently under review. Physician feedback is vital to the review process.

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Board-Certified Physicians Board-Certified Provider Specialization 52

Family Physicians of Greeley

JUNE 16, 2023

Understanding your insurance coverage, managing medical bills, and finding affordable healthcare options are essential for maintaining your health without breaking the bank. In this blog, we will provide you with practical tips to help you navigate insurance and healthcare costs effectively.

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FDA Law Blog

MARCH 25, 2025

Lenz, Principal Medical Device Regulation Expert Last year, FDA issued a letter to the medical device industry warning medical device firms of concerns related to fraudulent and unreliable laboratory testing data in premarket submissions, which we blogged about here. By Adrienne R.

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FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). By McKenzie E.

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Medical Manufacturing Healthcare Government 75

FDA Law Blog

MARCH 6, 2023

By Véronique Li, Senior Medical Device Regulation Expert — A year ago, we blogged about a proposed rule that would replace the Quality System Regulation (QSR) at 21 C.F.R. The Safe Medical Devices Act of 1990 provided FDA with the authority to include design controls in the regulation.

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Barton Associates

MAY 29, 2025

The United States doesn’t have enough doctors and the problem is only growing—according to the Association of American Medical Colleges (AAMC) , the country is facing an estimated shortage of between 13,500 and 86,000 primary and specialty care physicians by 2036. in April 2025. Where do physicians commonly work?

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FDA Law Blog

JUNE 26, 2024

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR.

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FDA Law Blog

APRIL 25, 2023

Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” Software as a Medical Device, or SaMD) or the software is embedded in a traditional hardware device (i.e., Software in a Medical Device, or SiMD).

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FDA Law Blog

OCTOBER 6, 2023

There is much to unpack, and we intend to do so in a series of blog posts. The end of enforcement discretion The PR proposes to phase out LDT “enforcement discretion” over a period of four years, after which most LDTs will be subject to all applicable medical device regulatory requirements.

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