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.”

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Medical Manufacturing Electronics Provider 23

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

AUGUST 23, 2022

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. After two negative tests, you should consider a molecular test, or call your healthcare provider.

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Individual Clinic Healthcare Provider 97

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 ). Finally, the policy emphasizes the importance of validation data, and states that FDA is providing EUA templates. academic medical center laboratories).

Manufacturing 52

Manufacturing Diagnose Diagnosis IT 52

FDA Law

JUNE 22, 2023

To obtain clearance of an OTC home IVD, a sponsor must provide the usual suite of analytical and clinical validation that would be required for any IVD, demonstrating adequate repeatability, stability, sensitivity, specificity, and so on. HbA1c, diagnosis of a particular virus, etc.). seeking treatment).

Manufacturing 59

Manufacturing Clinic IT Transportation 59

FDA Law

SEPTEMBER 26, 2024

In particular, CDRH touts its Breakthrough Devices Program, which it advertises as a “program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The reality, however, is quite different.

Clinic 64

Clinic IT Manufacturing Medical 64

FDA Law

JANUARY 26, 2022

By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming! With apologies to Rob Base and DJ EZ Rock , it took more than “two” to get this Emgality DTC TV commercial right (insert snare drum here please).

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IT Education Utilities Patient-Centered 40