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.

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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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FDA Law

MAY 29, 2025

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Principal Medical Device Regulatory Expert & Gail H. As we recently blogged about here and here , FDA has issued guidance on lifecycle management for AI-enabled device software functions. By Adrienne R.

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

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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.

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By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the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

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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

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

NOVEMBER 29, 2023

See our prior blog post on the topic here. 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).

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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.,

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FDA Law

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

SEPTEMBER 3, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Gibbs — Thank you to readers of this blog. 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.

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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.

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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).

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FDA Law

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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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.

Manufacturing 93

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FDA Law

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

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

SEPTEMBER 22, 2024

See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion. Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. By Steven J. Gonzalez & Lisa M. There is no cost associated with obtaining an FEI Number.

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FDA Law

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

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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Medical Provider IT Manufacturing 59

FDA Law

JUNE 14, 2021

The outcome was not a surprise, because the FDCA was designed for regulatory oversight of medical device manufacturing and distribution, not clinical laboratory testing. The background to this discussion is as follows: In 1976, Congress amended the FDCA to add a basic regulatory framework for medical devices.

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FDA Law

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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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.

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FDA Law

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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FDA Law

SEPTEMBER 29, 2023

For more than 30 years, FDA has asserted that it has jurisdiction to regulate LDTs as medical devices and clinical laboratories as manufacturers. As we have blogged about extensively over the years, FDA has initiated, but not completed, many efforts through different means to create a regulatory framework for LDTs.

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FDA Law

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

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

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. The American Conference Institutes popular FDA Boot Camp now in its 43rd iteration is scheduled to take place from March 19-20, 2025, at the NY Bar Association in New York, NY. And it is exactly that!

Manufacturing 59

Manufacturing Specialization Provider Clinic 59

FDA Law

NOVEMBER 6, 2022

Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. By Sophia R. Background.

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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.

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FDA Law

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

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.

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FDA Law

JUNE 27, 2023

By Véronique Li, Senior Medical Device Regulation Expert & Anne K. Walsh — Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here ).

Manufacturing 59

Manufacturing Utilities Electronics IT 59

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. And FDA did not provide a substantive response to 5 Requests for Advisory Opinions seeking clarification of the issue. 5429, the “ Medication Affordability and Patent Integrity Act.”

Manufacturing 105

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FDA Law

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

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 Performance Indicators.

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