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.” We have recently blogged on this topic (“ Is my software a medical device? ”). By Philip Won & Jeffrey K.

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Specialization Provider Medical Manufacturing 105

FDA Law

MAY 3, 2021

Maintaining complete and accurate records with direct, ongoing oversight by management reduces risk of internal employee pilferage and maximizes potential for early detection should diversion occur. We will discuss these actions in more detail in later blog.

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FDA Law

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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FDA Law

OCTOBER 9, 2023

We previously blogged about this lawsuit last year. To help patients afford the copays and deductibles for specific medications, some drug manufacturers offer direct financial assistance, often as coupons, to subsidize the patient’s purchase of the drug at the point of sale.

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FDA Law

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. We find that this information is noteworthy for manufacturers to consider.

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FDA Law

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

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Patient-Centered Manufacturing Clinic Provider 52

FDA Law

OCTOBER 10, 2022

You can find our preliminary blog post on the release of this guidance here , and our blog posts on the draft CDS guidances here and here. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information. Medical information about a patient.

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FDA Law

MAY 19, 2023

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. In addition, similar to what was required for an EUA, sponsors should evaluate cybersecurity of their system to ensure user and patient safety in the intended use environment.

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FDA Law

MARCH 6, 2025

Both guidance documents recommend data management practices for collecting data for use in developing, tuning, and testing an artificial intelligence model and making changes to said model.

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Manufacturing Management Clinical Practice Clinic 105

FDA Law

JUNE 14, 2023

He highlighted the following key features of TAP: An Innovative Approach To provide proactive support and guidance to medical device manufacturers, FDA has introduced a new CDRH position known as the “TAP Advisor.” Review teams already appoint a lead reviewer to each submission and sometimes assign a project manager to an extensive project.

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FDA Law

OCTOBER 17, 2023

In October 2022, FDA released the draft guidance entitled “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare,” as previously discussed in our blog. FDA will consider if technologies and device features “address unmet needs in these populations” when evaluating criterion one.

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Medical Diagnosis Healthcare Clinic 53

FDA Law

SEPTEMBER 8, 2022

Wasserstein — Three patient advocate groups have sued the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS), challenging HHS’s 2020 Notice of Benefits and Payment Parameters (NBPP) rule. The patient, on the other hand, is no closer to meeting their deductible than before.

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FDA Law

MAY 19, 2022

By Faraz Siddiqui — Last June, we blogged about a lawsuit brought by the Pharmaceutical Research and Manufacturers of America (PhRMA) challenging CMS’s ill-conceived Accumulator Adjustment Rule (“final rule”), which amended the Medicaid Rebate best price regulation. On Tuesday, May 17, 2022, the D.C.

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FDA Law

NOVEMBER 8, 2022

Torres also shared that the eSTAR program, which we most recently blogged about here , is being developed with Health Canada. To paraphrase from our blog post , EUAs are triggered by an EUA declaration; FDA will publish advanced notice for an EUA declaration and provide a 180 day notice before the implementation of the transition plan.

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