FDA Law Blog

APRIL 25, 2023

We have recently blogged on this topic (“ Is my software a medical device? ”). Users of eSTAR templates need to add attachments for cybersecurity risk management, cybersecurity management plan, continuing support plan, and cybersecurity labeling. Special 510(k)s. 510(k) exempt.

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ABIM

JUNE 17, 2025

Reau, MD Dr. Reau is ABIM Board Certified in Gastroenterology and Transplant Hepatology, specializing in viral hepatitis. It’s a much more practical and manageable way for me to maintain certification. The post The LKA is a practical approach to lifelong learning first appeared on ABIM Blog. By Nancy S.

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Vascular Physician

JANUARY 11, 2023

Depending on the procedure, an anesthesiologist will have a specifically tailored approach to how they administer and manage anesthesia from the beginning and till the end of the surgery. Post-Operative Anesthetic and Pain Management: Your level of pain and recovery from vascular surgery will depend on the complexity of your procedure.

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FDA Law Blog

MAY 19, 2023

In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device.

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FDA Law Blog

MAY 3, 2021

Maintaining complete and accurate records with direct, ongoing oversight by management reduces risk of internal employee pilferage and maximizes potential for early detection should diversion occur. We will discuss these actions in more detail in later blog.

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East Cary Family Physicians

JANUARY 30, 2024

As we embark on Glaucoma Awareness Month, East Cary Family Physicians is unwavering in our commitment to highlight the pivotal role of vision health, with a special emphasis on the early detection of glaucoma. Early detection not only facilitates effective management but also significantly reduces the risk of vision loss.

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Rao Doctor

APRIL 17, 2025

Introduction to Sprouts and Their Importance A Guide for Vegans and Health Enthusiasts on how to use a variety of sprouts to boost your health Hello friends, After my last two articles about Fever and Fever Management, I thought that I should write one about some nutritious and healthy eating item.

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The Clinical Problem Solvers

SEPTEMBER 30, 2020

Blog post – by Smitha Download CPSolvers App here Patreon website Melanie Fellay Melanie Fellay is the CEO and Co-Founder of Spekit, the leading in-app learning and digital enablement companion that helps employees learn their tools and navigate process changes by accessing training resources in real-time, everywhere they work.

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FDA Law Blog

JULY 17, 2024

As originally proposed, this new Committee could be convened in conjunction with the existing medical specialty area-focused advisory committees, akin to the Drug Safety and Risk Management Advisory Committee. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

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FDA Law Blog

MARCH 9, 2025

FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA25. You can access the conference brochure and sign up for the event here. Well see you at the conference!

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Vascular Physician

FEBRUARY 23, 2020

Vascular Institute of the Rockies 5-7 years of training after medical school specializing in learning about all aspects of peripheral vascular disease. Can also provide medical management, but if open surgery is the best option, they will refer the patient to a vascular surgeon. What is a Vascular Surgeon?

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Vascular Physician

OCTOBER 26, 2021

What is Hyperbaric Oxygen Therapy and How it Helps Heal Wounds Hyperbaric oxygen (HBO) therapy involves treating patients with 100% oxygen (O2) at elevated atmospheric pressures in a specially designed chamber. Wound care centers are increasing in popularity and offer coordinated multispecialty management of complex wound problems.

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FDA Law Blog

MARCH 3, 2025

Conference co-chairs include Derek Johnson (Managing Director and General Counsel, Portal Innovations) and Lulu Wang (Head of IP, Orna Therapeutics). FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. Hyman, Phelps & McNamara, P.C.s Hyman, Phelps & McNamara, P.C.s

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Specialization Provider Management 52

FDA Law Blog

MAY 3, 2021

Maintaining complete and accurate records with direct, ongoing oversight by management reduces risk of internal employee pilferage and maximizes potential for early detection should diversion occur. We will discuss these actions in more detail in later blog.

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Management Manufacturing Specialization IT 40

Vascular Physician

MARCH 6, 2023

They are essentially hollow tubes with thin walls and special flaps inside them called valves. If you've been diagnosed with a venous disease or are interested in protecting your vein health, there are practical steps you can take to manage and prevent symptoms.

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The Motivated MD

OCTOBER 10, 2024

Here are a few reasons: Overwhelmingly, index funds have lower expense ratios because they are passively managed. No significantly excessive charge is needed to manage a fund that just mimics a market index. Diversification is a strategy for managing risk by holding different types of investments within a portfolio (e.g.,

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Vascular Physician

DECEMBER 11, 2023

If you have been diagnosed with an AVF or are exhibiting signs of an AVF, be sure to work closely with your healthcare professional to manage the condition before it leads to other complications. They can determine if you need specialized care from the experiences team at Vascular Institute of the Rockies.

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IT Healthcare Appointment Diagnose 52

FDA Law Blog

JULY 26, 2021

cGMPs, adverse events monitoring, risk management and recalls. FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. Labeling in the drug and biologics approval process. Hyman, Phelps & McNamara, P.C.’s The discount code is: D10-806-806GX02.

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Vascular Physician

FEBRUARY 14, 2024

Types of Compression Therapy The two key types of compression therapy include graduated compression stockings and compression bandages: Graduated Compression Stockings These special stockings fit tighter than regular sock. Alternatives to compression therapy include leg elevation, exercise, weight management, and medications.

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FDA Law Blog

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. FDA Law Blog is a conference media partner for this event. The discount code is: S10-826-826L24.S.

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FDA Law Blog

OCTOBER 31, 2022

We have followed it over the last five years, with blog posts here , here , here , here , here , here , and here. It was noted that authorizing a device through a De Novo would create pilot specific special controls that other companies would need to follow, even if not participating in the pilot program. Key Findings at 12.

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FDA Law Blog

MAY 20, 2021

Houck — Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. The investigators may review suspicious order records and reports.

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FDA Law Blog

MAY 20, 2021

Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. The investigators may review suspicious order records and reports.

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FDA Law Blog

DECEMBER 2, 2024

We noted that the draft guidance’s discussion on determining a device’s contact duration raised concern as it contradicted ISO 10993-1:2018, Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management process. By Adrienne R.

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FDA Law Blog

MAY 27, 2024

She also specializes in medical device software and digital health. Ellison, Managing Director at HPM. She also managed the cross-functional team responsible for obtaining Apple’s first de novo authorizations for the ECG app and irregular rhythm notification.

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Physician's Practice

JUNE 20, 2025

Reynolds Blog Article Innovative medical practices thrive by embracing change, prioritizing patient care and learning from setbacks to enhance success and satisfaction. This blog will discuss what early adopters do to implement innovative and exciting practices. or less) on an appointment card.

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Management Patient-Centered Appointment Patients 52

FDA Law Blog

APRIL 6, 2025

Before her legal career, Julie worked as a nurse practitioner specializing in neurosurgery and infectious diseases. We look forward to her development and future success here, said HPM Managing Director J.P. During law school, Julie obtained practical litigation and transactional experience. Ellison.

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The Motivated MD

DECEMBER 18, 2024

I am using our weekly blog posts to create a future book that hopefully will apply to medical trainees and early career physicians looking to build generational wealth, get out of debt, and take control of their financial lives. If you have created a financial plan, use it to prioritize where this money should go.

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FDA Law Blog

FEBRUARY 19, 2024

Loloei also served as a Senior Policy Advisor in CDRH and as a Special Advisor in the Office of the Commissioner. Loloei will focus on guiding clients through complex premarket and postmarket regulatory requirements and assisting with the management of total product life-cycle matters. While at FDA, Ms. During her FDA tenure, Ms.

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FDA Law Blog

MAY 4, 2023

This draft guidance builds on recommendations that FDA initially developed early in 2020, in response to the COVID-19 challenges (see our blog post on these recommendations here ). For example, the draft guidance notes that the trial’s data management plan should include information about the multiple sources of data collection.

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FDA Law Blog

SEPTEMBER 26, 2022

FDA published a proposed list on June 13, 2018 (83 FR 27609), which we blogged about here. 211.167 – Special Testing Requirements: Manufacturers may be able to define “batch” based on the drug constituent part rather than the finished combination product for purposes of special testing requirements involving pyrogens and endotoxins.

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PEMBlog

AUGUST 30, 2023

This is a blog post and a podcast episode 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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FDA Law Blog

MAY 8, 2023

The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.

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GeriPal

MAY 19, 2022

As I’ve been blogging about this for a couple months now, I’m really trying to find anyone who loves these things. Drew: I’ve published a draft version of it on the blog. Eric: But is that just something special about methadone and buprenorphine? And is like, dang, like this… yeah, yeah, yeah.

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FDA Law Blog

JUNE 22, 2022

DEA regulations require “adequate security” but do not specially require cameras in health care facilities. The NPA requires “management” review of “any discrepancies discovered during an employee’s blind count when accessing controlled substances.” Positive test results must be reported to the appropriate licensing authorities.

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FDA Law Blog

FEBRUARY 22, 2023

And HF‑related AI requests are especially nerve‑racking to manage, because of the ever‑present threat that the study must be repeated to adequately respond. as a de novo special control or in a guidance document for a specific device type). Industry would certainly welcome guidance intended to smooth the HF aspects of 510(k) reviews.

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FDA Law Blog

NOVEMBER 20, 2024

Since the first issuance of FDA’s guidance Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” in 2016, sponsors submitting premarket submissions to FDA have had the option of using these techniques to evaluate certain biocompatibility endpoints.

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