FDA Law

DECEMBER 12, 2022

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — With the explosion of health‑related software, many software developers are generating products with functionality that is subject to regulation by the Food and Drug Administration (FDA).

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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 crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” . In this post, we focus on the proposed changes themselves, and the many questions the agency leaves unanswered.

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FDA Law

SEPTEMBER 21, 2022

This led to delays in releasing a uniform policy and templates for COVID-19, as well as many other problems (see blog post chronicling some of the challenges here ). academic medical center laboratories). We note that this policy defines an “experienced developer” more narrowly than the COVID-19 policy.

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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.

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FDA Law

AUGUST 23, 2022

Baumhardt, Senior Medical Device Regulation Expert & Richard A. These practical benefits are in marked contrast to molecular COVID-19 tests that are used for definitive diagnosis and are generally expected to detect the SARS-CoV-2 virus at least 95% of the time when someone is infected.

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FDA Law

SEPTEMBER 26, 2024

Newberger — We can all acknowledge that the title of this post is not that funny-at least, not to anyone other than medical device regulatory nerds, such as the author of this post. Manufacturers can expect increased interaction with the review team and prioritized review of the marketing submission.” By Jennifer D.

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FDA Law

OCTOBER 14, 2024

Note we do not discuss the cell expansion variety of this treatment further in this blog as the court quickly dispensed of it as obviously not subject to the SSP exception.) These procedures are offered to treat a variety of conditions, including Alzheimer’s, arthritis, asthma, cancer, etc., 21 U.S.C. §

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