FDA Law

OCTOBER 2, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Gail H. A draft guidance issued last year focused on PCCPs for devices incorporating artificial intelligence and machine learning (AI/ML), which we blogged about here ; this guidance has not yet been finalized.

Medical 59

Medical Specialization Manufacturing IT 59

ABIM

JUNE 17, 2025

Reau, MD Dr. Reau is ABIM Board Certified in Gastroenterology and Transplant Hepatology, specializing in viral hepatitis. She is currently Associate Director of Solid Organ Transplantation and Section Chief of Hepatology at Rush University Medical Center. By Nancy S.

Internal Medicine 40

Internal Medicine Board-Certified Patient-Centered Specialization 40

FDA Law

MAY 19, 2023

Baumhardt, Senior Medical Device Regulation Expert & Richard A. 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. analytical, clinical and stability).

Specialization 40

Specialization Clinic Provider IT 40

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. The last day to request a special accommodation for the fall 2025 traditional, 10-year MOC exam*.

Board-Certified Physicians 52

Board-Certified Physicians Board-Certified Provider Specialization 52

FDA Law

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).

Patient-Centered 105

Patient-Centered Community Medical Specialty Clinic 105

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. Rao’s Health Blogs where you can get access to many health articles like this one that I will be publishing from time to time.

Provider 130

Provider IT Specialization Healthcare 130

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. Medical conditions: Conditions such as diabetes, hypertension, and heart disease can increase the risk of glaucoma.

Primary Care Physician 40

Primary Care Physician Family Physician Screening Primary Care 40

FDA Law

FEBRUARY 13, 2025

Baumhardt, Principal Medical Device Regulatory Expert FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF).

Manufacturing 71

Manufacturing Management Specialization Provider 71

FDA Law

MARCH 27, 2023

Baumhardt, Senior Medical Device Regulation Expert — The Unique Device Identification (UDI) System final rule requires all medical devices to bear a unique numeric or alphanumeric code in easily readable plain-text and machine-readable form. So, what is special about September 24, 2023? By Philip Won & Lisa M.

Specialization 45

Specialization Supply Chain Manufacturing Medical 45

Vascular Physician

NOVEMBER 28, 2023

These include: Being overweight or obese Advanced age Psoriatic or rheumatoid arthritis Pregnancy Undergoing surgery Diagnosis and Medical Evaluation If you are exhibiting signs of lymphedema, do not wait to seek medical attention. Early diagnosis could mean a more effective treatment plan.

Treatment Plan 52

Treatment Plan Appointment Diagnose Healthcare 52

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. While it is possible for blood clots to be absorbed by your body and resolve on their own without any medical assistance, this is more common in blood clots that are small.

IT 52

IT Treatment Plan Diagnose Appointment 52

Vascular Physician

JANUARY 11, 2023

Fortunately, with the use of special nerve-blocking medications and long-acting painkillers, the pain and recovery from vascular surgery is often very mild. Depending on your surgery, your vascular surgeon and anesthesiologist will inform you of what to expect regarding recovery and pain.

Complication 52

Complication Patients Management Specialization 52

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.

Referral 40

Referral Management Complication Specialization 40

Vascular Physician

OCTOBER 10, 2022

Hyperbaric oxygen therapy is a type of treatment that involves a person lying in a special chamber with air pressure that is up to three times higher than normal air pressure. Hyperbaric oxygen therapy is preferred by medical professionals and patients alike thanks to the many benefits it can provide. What is Hyperbaric Oxygen Therapy?

Consulting 52

Consulting Specialization Diabetes IT 52

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

Provider 59

Provider Medical Manufacturing Consulting 59

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. Poor venous circulation can be caused by obesity, a sedentary lifestyle, aging, and certain medical conditions.

Healthcare Professional 52

Healthcare Professional Consulting Treatment Plan Healthcare 52

FDA Law

FEBRUARY 27, 2025

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. We look forward to seeing you at the conference.

Manufacturing 59

Manufacturing Specialization Clinic Provider 59

Aspiring Minority Doctor

JUNE 18, 2023

Additionally, this past week alone, a large number of former medical students who rotated with me during my intern year graduated from the shorter duration residencies in Internal Medicine, Family Medicine, etc and are now getting to do what they set out to do. When I was a premedical student, all I wanted to do was be a medical student.

Medical Student 52

Medical Student Medical IT Internal Medicine 52

FDA Law

JANUARY 24, 2024

FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. This in-depth training will include practical real-world examples that will help you to excel in your everyday practices. Join the “Who’s Who” of the FDA Bar and don’t miss your opportunity to join their ranks!

Specialization 59

Specialization Provider IT Medical 59

FDA Law

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. KP Medical Device Consulting LLC

Consulting 52

Consulting Medical Management Specialization 52

FDA Law

OCTOBER 31, 2022

Lenz, Principal Medical Device Regulation Expert — FDA began the Software Precertification (Pre-Cert) pilot program in 2017 to evaluate an alternative approach to regulation of software as a medical device (SaMD) over the total product lifecycle (TPLC). By Adrienne R. Key Findings at 12. Streamlined Review.

Manufacturing 72

Manufacturing Specialization Management IT 72

FDA Law

SEPTEMBER 22, 2022

While the authors did a yeoman’s job of combing through the criminal cases to identify what they view as a “handful” of cases and call for increased use of the Park doctrine, we at the FDA Law Blog respectfully disagree. The public may harbor similar doubts, leading prosecutors to avoid putting Park cases before juries.

Private Practice 59

Private Practice Government Individual Specialization 59

FDA Law

SEPTEMBER 30, 2022

This approval decision charts a path for the exercise of appropriate flexibility in regulatory decisions for other rare conditions where there is a serious and/or life-threatening unmet medical need, as is very often the case. We would like to acknowledge FDA for its efforts on this devastating condition, ALS.

Community 98

Community Provider Patients Specialization 98

FDA Law

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

Clinic 64

Clinic Clinical Practice Provider Utilities 64

FDA Law

AUGUST 18, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls provide reasonable assurance of safety and effectiveness for the intended use.

Specialization 69

Specialization Hospital Physicals Provider 69

FDA Law

MAY 27, 2024

HPM) proudly announces the return of Jennifer Newberger as a Director, further boosting its already robust medical device practice. She also specializes in medical device software and digital health. Hyman, Phelps & McNamara, P.C. Having worked with Jennifer for six years previously, I am truly excited to have her return.

Manufacturing 59

Manufacturing Management Utilities Relationship 59

FDA Law

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.

Provider 64

Provider Manufacturing IT Medical 64

FDA Law

OCTOBER 25, 2021

The Medical Device Amendments of 1976 created the initial premarket application (PMA) review and 510(k) substantial equivalence review processes. befitted a very important pathway to market for novel medical devices. Shapiro — After 23 years, de novo classification review finally has an implementing regulation ! Part 860.

Manufacturing 52

Manufacturing Government Specialization IT 52

FDA Law

NOVEMBER 6, 2024

Accordingly, FDA “provided a rational explanation of the differences between ordinary brief arousals and a prolonged sleep disruption caused by a second dosing of medication.” Black Ball Freight Serv. , 532, 539 (1970) (cleaned up).

Clinic 111

Clinic IT Patient-Centered Consulting 111

Aspiring Minority Doctor

MARCH 26, 2021

I'm finally ready to share a bit of my testimony, so read on if you'd like to know how God worked everything out in my favor :) If you've been following my blog, then you already know I was reapplying this year, but didn't want to share any details until after Match Day.

IT 52

IT Families Family Electronics 52

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. This week, we are tackling all things related to lifestyle creep. These posts may contain affiliate links.

Finance 52

Finance Insurance Individual IT 52

FDA Law

FEBRUARY 18, 2025

Only then should an expert delve into the application of those fundamental principles to the specifics of a patients medical file or dispensing history. First, DEA does not need to prove that the prescriptions in question were not issued for a legitimate medical purpose under the standard set forth in 21 C.F.R.

Government 69

Government Specialization Patients IT 69

FDA Law

MAY 3, 2021

We thought this would be a good time to post a series of blog posts focusing on DEA inspections and how registrants should prepare for and manage them, with a list of registrant do’s and don’ts. The CSA establishes classifications for drugs based on their potential for abuse relative to their legitimate medical use. 21 U.S.C. §

Management 52

Management Manufacturing Specialization IT 52

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.

Provider 75

Provider IT Engineering Medical 75

FDA Law

NOVEMBER 5, 2023

Dr. Won will share his expertise and insights on the intricacies of the United States Food and Drug Administration (FDA) regulations pertaining to medical devices, with a special focus on class II and class III hearing devices. Philip Won , of Hyman, Phelps & McNamara, P.C.

Engineering 52

Engineering Specialization Community Medical 52

FDA Law

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. Javitt — FDA recently published a long-awaited draft guidance aimed at reducing the need for prior FDA authorization of modifications to artificial intelligence/machine learning (AI/ML)-enabled device software functions (ML-DSFs).

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law

FEBRUARY 27, 2023

The Ryan Haight Act was enacted to address the legal “grey area” in which prescribers and pharmacies operated via the creation of two new statutory requirements: 1) the at least one “in-person” medical evaluation requirement for prescribing practitioners, 21 U.S.C. § 829(e); and 2) the modified registration requirement for online pharmacies.

Telemedicine 59

Telemedicine Telecommunication Telehealth Medical 59