FDA Law

DECEMBER 12, 2022

If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s an easy yes that you are a manufacturer of a medical device. or other similar or related article” which is “intended for use in the diagnosis of disease or other conditions.” Clinical Decision Support Software.

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Medical Manufacturing Electronics Provider 23

FDA Law

OCTOBER 14, 2024

The District Court in this case, which came to the opposite conclusion and is now reversed, was a notable outlier in a string of cases in other circuits upholding FDA’s authority to regulate stem cell clinics on similar grounds as the Ninth Circuit did here. Stem Cell Clinic, LLC , 998 F.3d Regenerative Sciences, LLC , 741 F.3d

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Clinic Patient-Centered Asthma Patients 59

FDA Law

JUNE 22, 2023

He also identified “Next-Generation Home-based Testing Technologies, including new IVDs, Digital Lateral Flow Readers, and Reporting Technologies” as an opportunity to “extend care from the hospital and clinic into the home setting.” HbA1c, diagnosis of a particular virus, etc.). HbA1c, diagnosis of a particular virus, etc.).

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Manufacturing Clinic IT Transportation 59

FDA Law

AUGUST 23, 2022

The 80% sensitivity requirement for antigen tests has yet to be explained either scientifically or clinically by the Agency. While this was a step in the right direction, only the tests whose clinical studies occurred during the Omicron surge had this stipulation included in their labeling.

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Individual Clinic Healthcare Provider 97

FDA Law

SEPTEMBER 26, 2024

What no one should find funny is how CDRH seems to be approaching Breakthrough devices of late, setting clinical study expectations so high that these innovative, novel, life-saving products may never get to the other side of the door, regardless of how much they knock. CDRH takes great pride in stating that it is committed to innovation.

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Clinic IT Manufacturing Medical 64

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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Provider Manufacturing IT Medical 64

FDA Law

NOVEMBER 18, 2021

Rapid tests for COVID-19 are fast, inexpensive to manufacture, and a relatively easy method to detect the presence of an active SARS?CoV?2 PCR) test is considered the gold standard for actual diagnosis. PCR comparators for their clinical studies but refuses to publicly designate which ones are acceptable. Why is that?

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