Minnesota Academy of Family Physicians

MARCH 27, 2025

2413 ( Senator Mann ) creates a new assessment on hospitals to increase Medical Assistance reimbursement rates. The Minnesota Hospital Association, as well as some individual hospitals, testified in support of the bill. Listing circumstances under which an individual health plan cannot be renewed. SENATE COMMERCE COMMITTEE S.F.

Family Physician 52

Family Physician Insurance Finance Individual 52

FDA Law

NOVEMBER 29, 2023

Focused and Bounded This guiding principle recommends that the PCCP describe a specific planned change that is consistent with the claimed intended use and intended purpose of the Machine Learning Medical Device (MLMD). Guiding Principle 10 focused on monitoring the performance of the models and managing re-training risks.

Management 115

Management Manufacturing Medical Healthcare 115

FDA Law

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications. See 21 CFR 807.81(a)(3)

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law

FEBRUARY 9, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R.

Clinic 105

Clinic Manufacturing Provider Electronics 105

FDA Law

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

FDA Law

JULY 25, 2023

Nitrosamines are chemicals that can form during drug manufacturing, known by their scientific names as N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The canary in the coal mine for nitrosamines was their 2018 appearance in blood pressure medications called sartans.

IT 52

IT Manufacturing Individual Medical 52

My Green Doctor

MAY 3, 2025

In This Issue : Why Renewable Energy Belongs in Every Clinic Medical Waste: One Model for Improvement OnTrack with your Sustainability Goals? Our Consulting Services offer customized strategies for group practices, health systems, and medical societies ready to accelerate their impact and lead the way in climate-smart care.

Healthcare 52

Healthcare Healthcare Professional Consulting Management 52

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. That could happen again.

Individual 97

Individual Clinic Healthcare Provider 97

FDA Law

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. It is intended to reduce regulatory burdens on medical device manufacturers and importers by enhancing global harmonization in device regulation. The final rule emphasizes risk management activities and risk-based decision making.

Manufacturing 59

Manufacturing Management Medical IT 59

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). FDA recommends including only a limited number of modifications in the PCCP.

Manufacturing 71

Manufacturing Management Specialization Provider 71

FDA Law

NOVEMBER 6, 2022

Pfizer manufactures tafamidis (sold under brand names Vyndaqel and Vyndamax), a breakthrough treatment for a rare, progressive heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM). If SCOTUS takes up this case, it could have significant and far-reaching implications across the healthcare fraud and abuse landscape. Background.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

Georgetown Pediatrics & Family Medicine

MAY 11, 2022

Purchase from well-recognized distributors, grocers, and pharmacies rather than individually sold or auction sites. Always mix formula as directed by the manufacturer. Check smaller stores and drug stores, which may not be out of supply when the bigger stores are. If you can afford it, buy formula online until store shortages ease.

Supply Chain 52

Supply Chain Specialization IT Family Medicine 52

FDA Law

JUNE 28, 2021

Under current Minnesota law enacted in May 2019, manufacturers that sell, deliver, or distribute into or within Minnesota 2 million or more units of an opiate are required to pay an annual product registration fee of $250,000. The companion bill was already passed by the Minnesota Senate and has a presentment date of today, June 28, 2021.

Hospital 52

Hospital Manufacturing Specialization Medical 52

FDA Law

FEBRUARY 23, 2025

Manufacturers must evaluate device changes in the first instance to determine whether a new 510(k) is needed or, instead, whether documentation of the change and rationale for not seeking 510(k) clearance is sufficient. Such assessments are highly individualized and difficult to map onto the few examples provided by FDA in its guidance.

Manufacturing 64

Manufacturing Provider Consulting IT 64

FDA Law

SEPTEMBER 19, 2023

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. Koblitz & Kurt R. Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. Avdel amicus brief).

Manufacturing 105

Manufacturing Provider IT Healthcare 105

FDA Law

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ). The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies.

Patients 52

Patients Clinic Medical Patient-Centered 52

GeriPal

JUNE 20, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

IT 120

IT Patient-Centered Patients Clinic 120

FDA Law

DECEMBER 12, 2022

How could the manufacturers even follow this guidance without illegally departing from their previously approved labeling? It is focused on excimer lasers with premarket application (PMA) approval for LASIK in product code LZS. This proposal is not, however, simply advice for preparation of an application for a new device. Public Comments.

Manufacturing 52

Manufacturing Provider Patients Medical 52

FDA Law

JUNE 22, 2023

Most recently, Jeff Shuren, CDRH Director, gave a speech at the 2023 Food and Drug Law Institute (FDLI) annual conference in which he identified facilitating “availability of and access to existing and novel home-use medical technologies” as a strategic priority for 2022-2023 to advance health equity. By McKenzie E. Cato & Jeffrey N.

Manufacturing 59

Manufacturing Clinic IT Transportation 59

FDA Law

OCTOBER 9, 2023

The ACA sets an annual cap on the amount that insurers can require insured individuals to pay out of pocket for their medical expenses. Once an individual reaches this annual cap, the insurer is solely responsible for covering the individual’s remaining medical expenses that year.

Insurance 40

Insurance Manufacturing Patient-Centered Individual 40

FDA Law

APRIL 22, 2024

Schedule IV substances are highly addictive and rarely used in medical practice while schedule I substances are also highly addictive, liable to abuse or convertible to drugs similarly addictive and liable to abuse. . § 811(d) required classification of marijuana as a schedule I or II substance to comply with U.S. 811(d) and U.S.

Manufacturing 59

Manufacturing Consulting IT Individual 59

FDA Law

SEPTEMBER 12, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Anne K. These classifications usually result from observations listed on the FDA investigator’s report (a Form 483).

Manufacturing 59

Manufacturing Provider Medical IT 59

FDA Law

DECEMBER 12, 2023

Acknowledging concerns about urolithiasis, pet food manufacturers use a range of formulation strategies to make UTH cat food, which have included limiting the magnesium content or formulating it to produce slightly acidic urine. Upper bound of 95% CI ≤ 2.5 CaOx: Mean RSS ≤ 6.0;

Utilities 59

Utilities Manufacturing Provider Individual 59

FDA Law

DECEMBER 13, 2022

Although on its face the restriction applies to LDTs, collection device manufacturers could, as a consequence, effectively be precluded from continuing to market their specimen collection devices to labs offering LDTs which enable home collection unless they first obtain authorization specifically for home collection. Javitt & Jeffrey N.

Telehealth 72

Telehealth Patients Manufacturing Transportation 72

GeriPal

MAY 5, 2022

We talk with Nick and Meg about: Why hearing loss is important not just in geriatrics but also for those caring for seriously ill individuals. Communication techniques we can use when talking to individuals with hearing loss. Think about the last time you attended a talk on communication skills or goals of care discussions.

IT 102

IT Screening Hospital Clinic 102

FDA Law

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 21 U.S.C. § 812(c)(c)(10).

Government 59

Government Medical IT Manufacturing 59

FDA Law

JANUARY 5, 2025

In discussing these revisions, FDA clarified that an ACNU failure must be reported even if the failure does not cause or lead to inappropriate medication use or consumer harm. 105288 (Dec. We described the 2022 proposed rule and the ten-plus year history leading up to its issuance in our blog post here.

Provider 59

Provider Healthcare Individual Manufacturing 59

FDA Law

OCTOBER 12, 2022

Most states have some form of naloxone standing order that allows a healthcare provider to write a prescription that covers a large group of people rather than just an individual patient. syringes), to any individual without a patient-specific prescription. plies for administration (e.g.,

Supply Chain 52

Supply Chain Individual Provider Patient-Centered 52

FDA Law

OCTOBER 14, 2024

The lowest risk category, which is not subject to any oversight by FDA, includes HCT/Ps removed from an individual that are implanted into the same individual during the “same surgical procedure.” Defendants may also seek en banc review of the decision from the full Ninth Circuit. Robbins , 519 U.S. 452 (1997); see also Kisor v.

Clinic 59

Clinic Patient-Centered Asthma Patients 59

FDA Law

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

Referral 59

Referral Relationship Government Healthcare 59

FDA Law

AUGUST 17, 2023

This statutory provision requires generic drugs to have the same labeling as that approved for the listed drug “except for changes required because of differences approved under a [suitability petition, allowing for certain differences] or because the new drug and the listed drug are produced or distributed by different manufacturers.”

Manufacturing 40

Manufacturing IT Medical Individual 40

FDA Law

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. The CDS Guidance interprets the Cures Act’s definition of “medical software” that is excluded from the statutory “device” definition, as it relates to CDS software.

Clinic 52

Clinic Medical Provider Patients 52

FDA Law

SEPTEMBER 20, 2021

STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs. In response, FDA memorialized its intention to use some of the new tools explored during the pandemic and potentially make them more permanent fixtures of facility inspections (e.g.,

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law

MAY 19, 2023

Baumhardt, Senior Medical Device Regulation Expert & Richard A. Final Release Criteria Special Controls Sponsors will need to provide the final manufacturing release criterion with evidence that lots released at the extremes of the specification will still meet the claimed device performance (i.e.,

Specialization 40

Specialization Clinic Provider IT 40

Physician's Weekly

JULY 1, 2025

” The study was funded by MannKind, the manufacturer of Afrezza. . ” The study was funded by MannKind, the manufacturer of Afrezza. . “Following what will hopefully be U.S. Press Release In another study, Nestoras Mathioudakis, M.D., ” Abstract No. 1956-LB Felicia L. . ” Abstract No. 1956-LB Felicia L.

Diabetes 52

Diabetes Patient-Centered Management Individual 52

FDA Law

DECEMBER 18, 2022

Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. The VMSR Program allows manufacturers to bundle malfunction reports of “like events” together in a single summary report. In that letter, FDA stated that it would “permit manufacturers.

Medical 59

Medical Manufacturing Individual Provider 59

GeriPal

MARCH 2, 2023

By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. One thing is clear, it is not because people are using it for FDA approved indications. The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96