FDA Law

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). By McKenzie E.

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The Medical Futurist

JUNE 21, 2025

Large language models will soon find their way in to everyday clinical settings , simply because the global shortage of healthcare personnel is becoming dire and AI will lend a hand with tasks that do not require skilled medical professionals. Current medical AIs only process one type of data, for example, text or X-ray images.

Healthcare 70

Healthcare Healthcare Professional Electronics Medical 70

FDA Law

MAY 6, 2024

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. are cybersecure.

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The Medical Futurist

JUNE 21, 2025

However, things are moving fast, and success doesn’t come easy for the pioneers of any medical field. Scientists at Columbia University Medical Center and the University of Iowa used CRISPR to repair a genetic mutation responsible for retinitis pigmentosa in induced pluripotent stem cells derived from a patient with the disease.

Diabetes 105

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FDA Law

OCTOBER 4, 2022

By Véronique Li, Senior Medical Device Regulation Expert — Allegations of regulatory misconduct are claims that a medical device manufacturer or marketers of medical devices operate in such a way that violates the law. This means there needs to be a better way to understand the outcomes of urgent issues.

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FDA Law

APRIL 2, 2024

In the first category, FDA asks Congress to amend the FDCA to require drug manufacturers to disclose full information about the name and quantity of inactive ingredients in product labeling and permit FDA to disclose to generic sponsors the names and amounts of such inactive ingredients.

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FDA Law

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). By McKenzie E.

Medical 75

Medical Manufacturing Healthcare Government 75

Medical Xpress

MAY 17, 2023

The study is by Dr. Daniel Weghuber, Department of Pediatrics, Paracelsus Medical University, Salzburg, Austria, and Dr. Rasmus Sørrig, Novo Nordisk A/S (the manufacturer of semaglutide), Søborg, Denmark, and colleagues.

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FDA Law

MARCH 24, 2024

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state.

Manufacturing 59

Manufacturing Government IT Provider 59

FDA Law

MARCH 7, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Now, FDA is granting a waiver of annual registration fees, per the draft guidance for Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance. The catch: the company has to be small and bankrupt.

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FDA Law

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act.

Manufacturing 59

Manufacturing Supply Chain Provider Treatment Plan 59

Plum Health

AUGUST 30, 2024

Mike to discuss affordable GLP-1 medication! These are groundbreaking medications that not only help regulate blood sugar but also support weight loss. Ozempic is classified as a glucagon-like peptide-1 ( GLP-1) agonist , a type of medication that imitates the actions of a gut hormone known as GLP-1. Ozempic injection pen.

Primary Care 52

Primary Care Insurance Diabetes Manufacturing 52

FDA Law

JANUARY 9, 2025

As part of the Food and Drug Administration Safety and Innovation Act (known as FDASIA) and later under the FDA Reauthorization Act of 2017 (known as FDARA), a drug or medical device can be deemed adulterated if a regulated company delays, denies, or limits an inspection, or refuses to permit an entry or inspection. FD&C Act 501(j).

Manufacturing 105

Manufacturing Management IT Medical 105

FDA Law

JUNE 2, 2025

As HPM argued in both the groundbreaking citizen petition Jeffrey Gibbs filed thirty-two years ago and the papers we filed on behalf of our clients, Dr. Michael Laposata and the Association for Molecular Pathology in the recent LDT litigation, the Federal, Food, Drug, and Cosmetic Act does not authorize FDA to regulate LDTs as medical devices.

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IT Manufacturing Government Clinic 64

FDA Law

MAY 29, 2025

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Principal Medical Device Regulatory Expert & Gail H. By Adrienne R. FDA has been working for years to understand the complexity of AI and how to ensure it functions as intended.

Manufacturing 102

Manufacturing Patient-Centered Medical Management 102

Medical Xpress

APRIL 8, 2023

Messenger Ribonucleic Acid (mRNA) as a therapeutic approach is gaining momentum due to its ability to be rapidly manufactured and its promising outcomes. mRNA-based vaccines, for instance, played a crucial role in the fight against COVID-19 in many parts of the world.

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FDA Law

MARCH 25, 2025

Lenz, Principal Medical Device Regulation Expert Last year, FDA issued a letter to the medical device industry warning medical device firms of concerns related to fraudulent and unreliable laboratory testing data in premarket submissions, which we blogged about here. By Adrienne R.

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FDA Law

JUNE 22, 2025

While in the present case, the manufacturer, retailer, and trade association were all part of the same lawsuit, nothing in the Court’s decision requires that the applicant be a party to such a challenge. By JP Ellison — Last Friday, the Supreme Court delivered a trio of decisions making it easier to litigate against the federal government.

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FDA Law

FEBRUARY 7, 2023

Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. Part 830), post-market surveillance studies (Section 522 of the FD&C Act), medical device tracking (21 C.F.R.

Manufacturing 98

Manufacturing Medical Engineering IT 98

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)

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FDA Law

AUGUST 15, 2021

Shapiro — A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. The proposal was to remove the “knowledge provision,” which had always seemed to problematically suggest that a manufacturer could be held responsible for off?label label use if the manufacturer knew about it.

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Manufacturing IT Provider Government 93

Annals of Family Medicine

NOVEMBER 20, 2024

Setting: 3 academic medical centers. FIT manufacturers should develop very clear directions for patients. Study Design/Analysis: Prospective; participants completed 5 unique FITs according to those most commonly used. Population Studied: 2148 individuals aged 50 to 85 years scheduled for screening or surveillance colonoscopy.

Screening 130

Screening Patients Individual Patient-Centered 130

FDA Law

AUGUST 4, 2022

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. Pfizer, Inc. Department of Health and Human Services et al. July 25, 2022. Whether the Beneficiary Inducement Statute (BIS) is relevant to interpreting the AKS (essentially, no). Background.

Manufacturing 98

Manufacturing Medical Government IT 98

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.

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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. Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device.

Provider 59

Provider Medical Manufacturing Consulting 59

FDA Law

MARCH 6, 2023

By Véronique Li, Senior Medical Device Regulation Expert — A year ago, we blogged about a proposed rule that would replace the Quality System Regulation (QSR) at 21 C.F.R. The Safe Medical Devices Act of 1990 provided FDA with the authority to include design controls in the regulation.

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Medical Xpress

MAY 1, 2023

Mejias had been taking a drug to treat a rare skin disease for about two years when its manufacturer effectively cut off his supply.

Manufacturing 99

Manufacturing Patients IT Medical 99

Medical Xpress

DECEMBER 7, 2022

US e-cigarette manufacturer Juul Labs said on Tuesday it had reached a settlement with about 10,000 plaintiffs in California after the company was accused of marketing its products to teenagers.

Manufacturing 98

Manufacturing 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

APRIL 25, 2023

Shapiro — Does your firm manufacture a “cyber device”? Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” Software as a Medical Device, or SaMD) or the software is embedded in a traditional hardware device (i.e.,

Specialization 105

Specialization Provider Medical Manufacturing 105

Medical Xpress

DECEMBER 22, 2022

Japan has approved a blood test kit to diagnose Alzheimer's disease, its manufacturer announced on Thursday, a rare advance in tackling a condition that affects tens of millions worldwide.

Manufacturing 98

Manufacturing Diagnose IT 98

FDA Law

AUGUST 16, 2022

Farquhar — Those of us who work frequently on FDA inspections of drug and medical device manufacturing facilities have noticed an uptick in regular inspections after a dramatic falloff during the first two years of COVID. By Douglas B. Mr. Cruse pledged that the frequency of these inspections would increase.

Manufacturing 98

Manufacturing Complication Medical IT 98

FDA Law

OCTOBER 2, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Gail H. By Adrienne R. Change Guidance at 8.

Medical 59

Medical Specialization Manufacturing IT 59

FDA Law

JUNE 28, 2022

This consolidated case has implications not only for prescribers of controlled substances but also for pharmacists and pharmacies who are subject to a “corresponding responsibility” to only fill prescriptions issued for a legitimate medical purpose pursuant to the Controlled Substances Act (21 U.S.C. § Gilbert & Karla L. 21 U.S.C. §

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Government Manufacturing Medical IT 98

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

FDA Law

AUGUST 30, 2021

By Philip Won — On June 17, 2021, FDA has released a discussion paper to discuss cybersecurity issues related to the servicing of medical devices. FDA is now expanding its cybersecurity effort in servicing of medical devices. What are the cybersecurity challenges and opportunities associated with the servicing of medical devices?

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