Minnesota Academy of Family Physicians

FEBRUARY 20, 2025

Through food pharmacies, food insecurity screenings and innovative community partnerships, health care providers are ensuring patients get the nourishment they need to thrive. M Health Fairview’s Fair Table program ensures convenient access to food during medical appointments. Do you have resources to share with other members?

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East Cary Family Physicians

JANUARY 30, 2024

In this blog post, we’ll explore the importance of vision screenings, especially during Glaucoma Awareness Month, and how they play a crucial role in preserving your eyesight. Regular vision screenings are essential to catch glaucoma early, allowing for timely intervention and the preservation of vision.

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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. The excellent information is that online endocrinologists comply with the equal medical suggestions and standards as conventional clinics. What Is Hormonal Therapy?

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PEMBlog

SEPTEMBER 6, 2023

This is a blog post designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not.

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Lab Testing Medical Patients Mental Health 52

FDA Law

OCTOBER 24, 2023

Currently, eSTAR is voluntary for medical device De Novo submissions, but FDA has initiated the process of requiring De Novos to be submitted using eSTAR. On September 29, 2023, FDA released a draft guidance on Electronic Submission Template for Medical Device De Novo Requests.

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FDA Law

OCTOBER 5, 2022

Instead, it will go through a virus scanning and technical screening process to verify that eSTAR responses accurately describe the device and there is at least one applicable attachment per relevant attachment-type question. eSTAR will be mandatory October 1, 2023 for all 510(k) submissions and subsequent supplements and amendments (e.g.

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FDA Law

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. KP Medical Device Consulting LLC

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FDA Law

SEPTEMBER 29, 2023

For more than 30 years, FDA has asserted that it has jurisdiction to regulate LDTs as medical devices and clinical laboratories as manufacturers. As we have blogged about extensively over the years, FDA has initiated, but not completed, many efforts through different means to create a regulatory framework for LDTs.

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Aspiring Minority Doctor

APRIL 17, 2021

Not sure if it will help anyone, and I made sure to retract program names, so just posting on the blog for my memories. By the time most medical students get ready to apply for residency, they have already spent thousands of dollars just taking board exams alone, not to mention the other costs associated with being a medical student.

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FDA Law

NOVEMBER 6, 2023

Admittedly, BiMo inspections (into items like adequacy of bioequivalence data, consistency of clinical trial data with medical records, and compliance with clinical trial protocols) lend themselves better to an RIE than assessing manufacturing compliance with regulatory requirements. We should explain what RIEs are.

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PEMBlog

AUGUST 28, 2023

There will be episodes of PEM Currents: The Pediatric Emergency Medicine Podcast, blog posts here on PEMBlog, articles from Don’t Forget the Bubbles , videos, and more! Do not obtain screening laboratory tests in the medical clearance process of pediatric patients who require inpatient psychiatric admission unless clinically indicated.

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Vascular Physician

OCTOBER 10, 2022

To diagnose this condition, your physician may perform screening tests, such as an ankle-brachial index test (ABI). Finally, a medication called Cilostazol is occasionally prescribed to help with symptoms of cramping. An ABI less than 0.9 indicates that your legs and feet are not receiving as much blood flow as required.

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FDA Law

SEPTEMBER 17, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — Over the last three and a half years, meetings with FDA were conducted virtually. If you are driving, stop at the vehicle screening facility and inform security that you are attending a meeting. Getting to Building 66 Most CDRH meetings occur in Building 66.

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FDA Law

JUNE 8, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — On May 11, 2023, the U.S. CDRH As of this blog post, CDRH has not made any official announcements regarding the resumption of in-person meetings. The pandemic had changed the way people live, work and communicate.

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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.

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Vascular Physician

JULY 11, 2021

Evaluation begins with three screening questions: Are your fingers or toes unusually sensitive to cold? Very few patients with Raynaud's should be offered drug treatment, because the side effects of the medications are more dangerous than the Raynaud's they are used to treat. How is Raynaud's Phenomenon diagnosed?

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FDA Law

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne R.

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FDA Law

AUGUST 23, 2022

Baumhardt, Senior Medical Device Regulation Expert & Richard A. These recommendations come based on the latest National Institutes for Health (NIH) and University of Massachusetts Chan Medical School study which was funded by the NIH Rapid Acceleration of Diagnostics (RADx) program.

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FDA Law

DECEMBER 6, 2023

FDA tries to justify the proposed rule by claiming that LDTs present significant risks, and that the solution is to regulate them all as medical devices. Tests such as genetic testing of prospective parents, prenatal screening, cancer prognosis, and testing for rare diseases play a critical role in the health care system.

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PEMBlog

SEPTEMBER 13, 2023

This is a blog post designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not. Glucose We all need it.

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FDA Law

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

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FDA Law

MAY 25, 2022

Javitt — On April 19, FDA issued a safety communication regarding genetic non-invasive prenatal screening, commonly referred to as non-invasive prenatal tests or NIPT ( here ). NIPT are intended to screen for genetic abnormalities in a fetus. Mullen & Jeffrey N. Gibbs & Gail H.

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FDA Law

NOVEMBER 2, 2023

This program is modeled after a similar program in place for medical devices, the formal standards and conformity assessment program (S-CAP). Because this is a relatively new field that has exploded in recent years in terms of the diversity of medical products, there are a lot of unanswered questions as to how this can be demonstrated.

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FDA Law

NOVEMBER 28, 2023

The notice ( here ) indicates that FDA plans for the panel to “discuss and make recommendations on the design of multi-cancer detection (MCD) in vitro diagnostic devices (tests) as well as potential study designs and study outcomes of interest that could inform the assessment of the probable benefits and risks of MCD screening tests.”

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FDA Law

MAY 17, 2021

suited for, like back to work screening. Since when has FDA been authorized to to abjure premarket review of a medical device whenever it chooses to do so, other than pursuant to express regulations placing a device in Class I or II and designating it as 510(k) exempt? FDA has not followed that procedure for LDTs.

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FDA Law

MAY 17, 2021

suited for, like back to work screening. Since when has FDA been authorized to to abjure premarket review of a medical device whenever it chooses to do so, other than pursuant to express regulations placing a device in Class I or II and designating it as 510(k) exempt? FDA has not followed that procedure for LDTs.

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Mesa Family Physician

JUNE 11, 2025

In this blog, we’ll break down what preventive care involves, explore its relationship with short-term health insurance, and explain why it’s a critical part of staying healthy at any stage of life. Preventive care includes medical services and healthy habits designed to stop diseases before they start. What Is Preventive Care?

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Adventures of a Sick Doctor

JUNE 5, 2021

I've been neglecting this blog. I write a column in a medical newspaper every couple of months, and that absorbs my writing energy. I glanced at the screen occasionally to watch the wonderful new President Dr Ina Kelly and her colleagues deliver their speeches. 87% had to cover out-of-hours shifts on top of that.

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FDA Law

NOVEMBER 18, 2021

A positive result, however, is treated as a screen. That is just another way of saying, however, that the rapid antigen tests are best positioned as a screening tool. These tests could have been a valuable screening tool for COVID during the past year or so. A follow up laboratory?run run molecular diagnostic (RT?PCR)

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GeriPal

JANUARY 18, 2024

After discussing screening options for substance use disorder, we go on to talk about both the treatments for it and the issues that arise. And you wrote, actually, a beautiful GeriPal blog about it a while ago. I mean, the simple answer is, yes, we should be screening people for substance use disorder. What is it called?

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PEMBlog

MAY 15, 2023

The majority of these are cardiac and so today we will review what to look for in your screening ECG. Your history and medication reconciliation will assist in determining acquired vs congenital variants. Acquired long QT can be caused by electrolyte disorders, eating disorders and/or medications. Larkin, John, et al.

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Vascular Physician

MARCH 29, 2022

Consequently, screening for additional aneurysms upon diagnosis is highly recommended. Initial screening modalities include bilateral ultrasound (US), with CT angiography of the lower extremity if US results are inconclusive. cm in diameter.

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Noreta Family Medicine

APRIL 17, 2024

During our post-medical school residency years, we are trained by many different types of doctors including pediatricians, OB/GYNs, surgeons, psychiatrists, neurologists, ENTs and more. Don’t worry; HIPAA laws protect your privacy and medical information. to your last day on Earth, as I like to say!

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FDA Law

JULY 7, 2024

The guidance restates the central premise of the final rule, i.e., that LDTs are medical devices and the clinical laboratories that design, manufacture and use them to test patient specimens are manufacturers. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

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FDA Law

NOVEMBER 29, 2022

We blogged on the 2016 guideline here in March 2016, and the proposed guideline here on March 18th). Payers, health systems, and state medical boards should not use the guideline to set rigid standards or performance incentives related to opioid dosage or opioid therapy duration. 2022 Guideline at 15. (We 2022 Guideline at 3.

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FDA Law

FEBRUARY 22, 2022

The NIH screens manufacturers to ensure they have reputable tests already in use in other countries with good supporting test data. While we have seen FDA grant serial screening claims to antigen tests, we have not seen FDA authorize an antigen test that required serial testing to meet the minimum performance requirement.

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FDA Law

JULY 9, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks & Deborah L. We’ve blogged about some of FDA’s efforts to increase diversity in clinical trials previously, and the Draft Guidance itself describes a variety of these efforts. 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)).

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