FDA Law Blog

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Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Gail H. A draft guidance issued last year focused on PCCPs for devices incorporating artificial intelligence and machine learning (AI/ML), which we blogged about here ; this guidance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.

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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. 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.

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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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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

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).

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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. Early diagnosis could mean a more effective treatment plan.

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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. Because vascular surgeons have the skills to provide every treatment of vascular disease, they can help individualize the treatment of each patient to what will work best for them.

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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.

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

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FDA Law Blog

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). FDA provides definitions for the three datasets. Update practices and training of end users also need to be addressed.

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FDA Law Blog

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.

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

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FDA Law Blog

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. emphasis added).

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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

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

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.

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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

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

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FDA Law Blog

MAY 27, 2024

(HPM) proudly announces the return of Jennifer Newberger as a Director, further boosting its already robust medical device practice. Jennifer’s combination of experiences as in-house counsel for both large and start-up companies as well as outside counsel provides clients invaluable expertise and problem-solving skills.

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FDA Law Blog

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.

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FDA Law Blog

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. FDA recommends that PCCPs specify only a “limited number” of modifications but does not provide a limit on the number of modifications that can be included.

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FDA Law Blog

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 Blog

MAY 4, 2023

In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories. 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 ).

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FDA Law Blog

NOVEMBER 6, 2024

And, the Court said, Jazz’s critiques of FDA’s findings do not “rise[] to arbitrary and capricious agency decision-making.” As of now, FDA’s approval of Lumryz stands, as does its authority to abrogate an orphan exclusivity period when a follow-on product is clinically superior.

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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. Don’t try to beat the market; be the market.

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FDA Law Blog

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.

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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. I do not provide nor engage in rendering legal, accounting, or other professional services.

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Finance Insurance Individual IT 52

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

MAY 7, 2025

Gonzalez There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. Walsh & Sophia R. Gaulkin & Steven J. This scrutiny was enhanced after the Fourth Circuits ruling in United States v. Mallory , 988 F.3d Polin , 194 F.3d

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FDA Law Blog

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.

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FDA Law Blog

SEPTEMBER 26, 2022

Lenz, Principal Medical Device Regulation Expert & Holly N. requires generally that manufacturing of a combination product (CP) must comply with the applicable current Good Manufacturing Practice regulations (cGMPs) for all of its components ( i.e., a drug/device CP must follow the cGMPs for drugs as well as those for medical devices).

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FDA Law Blog

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. Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. 21 U.S.C. § 21 U.S.C. § 21 U.S.C. §

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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

JUNE 28, 2021

On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services bill. If enacted, Article 5, Section 6 of HF33 would provide for a reduction to the State’s opiate product registration fee.

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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.”

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FDA Law Blog

JULY 12, 2022

As discussed in our prior post on the CCP ( here ), the CCP is currently a submission tracker providing details of completed and upcoming dates. The pilot will be available to applicants planning to submit Traditional, Special, or Abbreviated 510(k)s. The first relates to the Customer Collaborations Portal (or CCP).

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FDA Law Blog

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

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