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.” We have recently blogged on this topic (“ Is my software a medical device? ”). This provision became effective as of March 29, 2023. Software in a Medical Device, or SiMD).

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ABIM

MAY 7, 2025

Blueprints provide an outline of what content will appear on an assessment and the relative percentage of the assessment covered by each topic area. During this process, Item-Writers will often provide feedback and societies provide their own perspectives on behalf of their members.

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FDA Law Blog

OCTOBER 16, 2023

Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Javitt & Steven J. 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.

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Logansport Memorial Hospital

APRIL 23, 2024

In this blog article, Dr. Scott Marsh, our podiatrist here at Logansport Memorial, shares some tips to keep your feet healthy. Wearing sandals around the pool is okay, but avoid wearing them daily as they do not provide adequate support for your feet. Pain in your feet is not normal. Consider trying a sandal with arch support.

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FDA Law Blog

AUGUST 23, 2021

These revisions appear to be responsive to a November 16, 2020 Special Fraud Alert issued by the Office of Inspector General at the U.S. Department of Health and Human Services (OIG) (see our blog post on this Special Fraud Alert here ). not friends, significant others, or family members of a speaker or invitee).

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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. Javitt & Philip Won — As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs). In this post, we focus on the proposed changes themselves, and the many questions the agency leaves unanswered.

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FDA Law Blog

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

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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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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 It Used For?

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Vascular Physician

NOVEMBER 28, 2023

Other signs of lymphedema include: Feeling tightness or heaviness in the affected area Thickening of the skin Frequent infections It is best to schedule an appointment with your healthcare provider as soon as you notice one or more symptoms of lymphedema. It is caused by rare conditions that are inherited.

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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. Glaucoma, often referred to as the “silent thief of sight,” can lead to irreversible vision loss if left untreated.

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FDA Law Blog

APRIL 6, 2025

For nearly two decades, Dr. Lowy provided leadership across a range of important therapeutic areas, including general endocrinology, pain/opioids, cardiology, neurology, and psychiatry. Before her legal career, Julie worked as a nurse practitioner specializing in neurosurgery and infectious diseases.

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FDA Law Blog

FEBRUARY 27, 2025

The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. As such, we can offer our readers a special 10% discount. And it is exactly that! The discount code is: D10-999-FDA25. You can access the conference brochure and sign up for the event here.

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FDA Law Blog

FEBRUARY 13, 2025

The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ). FDA provides definitions for the three datasets.

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FDA Law Blog

NOVEMBER 20, 2024

The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting. However, it is very common to have “tentative” or “unknown” identifications in chemical characterization studies.

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FDA Law Blog

JANUARY 24, 2024

The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. Karst (Director, Hyman, Phelps & McNamara, P.C.) The discount code is: D10-999-FDA24.

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FDA Law Blog

OCTOBER 2, 2024

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. Change Guidance at 8. Draft Guidance at 34.

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FDA Law Blog

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. So, what is special about September 24, 2023? Most of the compliance dates have been passed. Emphasis added.) It is not far off!

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The Motivated MD

OCTOBER 10, 2024

So, with this chapter, I hope to briefly touch on the basics of market investing and describe why simple diversification and index fund investing are the most effective ways for busy clinical physicians and healthcare providers to invest with the expectation of long-term gains. it wins in the long run by growing as the economy does.

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PEMBlog

SEPTEMBER 20, 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. 2014;58(2):258-274.

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FDA Law Blog

NOVEMBER 6, 2024

Starting in 2022 with a patent certification requirement, both Jazz and Avadel have sued FDA over this drug, with Jazz most recently bringing suit challenging FDA’s decision that Avadel’s Lumryz (sodium oxybate) is clinically superior to Jazz’s Xywav (sodium oxybate) in 2023. This case followed. The Court held that it does.

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FDA Law Blog

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).

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FDA Law Blog

SEPTEMBER 30, 2022

Dunn suggested that we look to FDA’s previous approval decisions to understand just how much uncertainty can be accepted, sighting in ALS to previous approval decisions that did not provide traditional efficacy evidence. By Frank J. Sasinowski & James E. We would like to acknowledge FDA for its efforts on this devastating condition, ALS.

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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. ’ Having a high income and being wealthy are not synonymous. What is Lifestyle Creep?

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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. If left untreated, it could lead to ulcers and in some cases limb loss.

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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

JULY 26, 2021

The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: D10-806-806GX02. We look forward to seeing you at the conference.

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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. Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. By Philip Won & Adrienne R.

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FDA Law Blog

SEPTEMBER 25, 2024

It provides a perspective on Hatch-Waxman that only a few folks out there (and dwindling) can provide.

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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

AUGUST 18, 2024

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. The classification order identifies the special controls and therefore is extremely important.

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FDA Law Blog

MAY 8, 2023

See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a) a) , and related guidance documents (e.g., here for a 510(k) device and here for a PMA device). The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).

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FDA Law Blog

DECEMBER 7, 2023

There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention. In his conference keynote address , Arun Rao—the Deputy Assistant Attorney General for DOJ’s Consumer Protection Branch—provided an overview of DOJ’s year in FDA enforcement.

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FDA Law Blog

APRIL 14, 2022

Over the course of two days, this event will provide impactful and practical programming all geared towards assessing the implications and imprimaturs of court cases, legislation, and industry behaviors which affect the patent endgame and the pursuit of related profits. FDA Law Blog is a conference media partner.

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FDA Law Blog

OCTOBER 25, 2021

It was published approximately three years after the December 7, 2018 release of the proposed rule (see blog post on the proposed rule here ). As to the testing facility inspections, without more explanation than was provided in the preamble, it is not clear how section 513(a)(1)(C) provides authority. Part 860.

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FDA Law Blog

OCTOBER 5, 2022

CDRH’s website provides a link to request access to the CCP ( here ). According to CDRH’s website, “When you send a CDRH 510(k) submission (traditional, special, and abbreviated 510(k)s) for review, your official correspondent can monitor the FDA’s progress online in a simple, concise format.” By Allyson B.

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FDA Law Blog

DECEMBER 2, 2024

We have seen this come up in many device reviews over the last several years, so we are not surprised to see it make its way to the draft guidance, but the justification for this burdensome approach is not provided and having conflicting recommendations in two related documents (i.e., By Adrienne R.

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