FDA Law Blog

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 acknowledgment will include an FDA-assigned identification number for the allegation report.

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FDA Law Blog

MARCH 19, 2024

is pleased to announce that Director Allyson Mullen has been appointed to the Board of Directors of the Association of Medical Diagnostic Manufacturers (AMDM). Mullen brings to the AMDM board a wealth of knowledge and expertise gained from her years of providing counsel to medical device and IVD manufacturers.

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FDA Law Blog

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.

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FDA Law Blog

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). products intended for medical purposes).

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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.

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FDA Law Blog

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. Code Ann. § 23-92-604(c)(1), (2) (Act 1103).

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FDA Law Blog

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.

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FDA Law Blog

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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The Medical Futurist

JUNE 21, 2025

Researchers say that the implant cannot provide any highly detailed vision – but it can help patients detect distinct patterns such as door frames and shapes. However, things are moving fast, and success doesn’t come easy for the pioneers of any medical field.

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FDA Law Blog

MAY 29, 2025

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Principal Medical Device Regulatory Expert & Gail H. Therefore, it seems reasonable that AI models could be trained on the data, provide useful insights to reviewers, and speed up review times. By Adrienne R.

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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.

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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. Reynolds Vapor Co. , Nor does the analysis limit the statute’s scope to retailers. In Diamond Alternative Energy, LLC v. McKesson Corp.,

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FDA Law Blog

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.

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FDA Law Blog

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.

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FDA Law Blog

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 Blog

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.,

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FDA Law Blog

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. Change to the IVD definition First, the mechanics of the change.

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FDA Law Blog

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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FDA Law Blog

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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FDA Law Blog

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.

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FDA Law Blog

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). The plan should identify the methods for verifying and validating the change.

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Minnesota Academy of Family Physicians

MARCH 27, 2025

As we move into the tenth week of the legislative session, Minnesota Academy of Family Physicians (MAFP) lobbyist Megan Verdeja breaks down what’s happening at the Minnesota State Capitol and provides an update on health care bills. 1878 ( Representative Keeler ) would cover traditional health care practices under Medical Assistance.

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FDA Law Blog

OCTOBER 2, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Gail H. If a sponsor is able to provide a detailed description of multiple changes with appropriate performance evaluation methods for each, we hope the Agency will be willing to consider them under a single PCCP.

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FDA Law Blog

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.

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FDA Law Blog

AUGUST 6, 2021

We are similarly at a loss to understand the purpose of Facebook’s new policy requiring that pharmaceutical manufacturers, telehealth companies, and online pharmacies apply for permission to advertise on Facebook. Nor does the policy apply to prescription medical devices which we’ve also seen advertised endlessly on Facebook. (Hey,

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Medical Xpress

APRIL 11, 2023

In the process of organoid manufacturing, bioprinting technology can not only facilitate the creation and maintenance of complex biological 3D shapes and structures, but also allow for standardization and quality control during production.

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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.

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FDA Law Blog

SEPTEMBER 3, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Given the high rate of innovation in the device industry, including the evolving field of AI, we expect more manufacturers to either submit De Novo classification requests or rely on those for their 510(k) devices. Gibbs — Thank you to readers of this blog.

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FDA Law Blog

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term. . does not use this term.

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FDA Law Blog

SEPTEMBER 22, 2024

Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. By Steven J. Gonzalez & Lisa M.

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FDA Law Blog

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. § 21 U.S.C. § 841 (emphasis added).

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FDA Law Blog

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.

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FDA Law Blog

SEPTEMBER 27, 2022

Baumhardt, Senior Medical Device Regulation Expert & Richard A. The program began accepting proposals on September 7, 2022, from manufacturers that have existing technologies and can scale production, while meeting FDA quality requirements.

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FDA Law Blog

JANUARY 5, 2022

Lenz has become its first Principal Medical Device Regulation Expert. She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. Hyman, Phelps & McNamara, P.C. (HP&M) HP&M) is pleased to announce Adrienne R. Adrienne joined HPM in September 2017.

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FDA Law Blog

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.

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FDA Law Blog

NOVEMBER 15, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — In our last blog post , we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. In this blog post, we provide a primer on user fees and the Small Business Program.

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FDA Law Blog

JANUARY 5, 2022

Lenz has become its first Principal Medical Device Regulation Expert. She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. Hyman, Phelps & McNamara, P.C. (HP&M) HP&M) is pleased to announce Adrienne R. Adrienne joined HPM in September 2017.

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