In-Vitro Reagent Research 
ProRelix Research
JUNE 26, 2023
As per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, […] The post US FDA Medical Device Applications appeared first on ProRelix Research.
FDA Law Blog
AUGUST 3, 2022
If anything, the announcement was remarkably inconspicuous: a seemingly throwaway sentence in a draft compliance policy guide for research use only and investigational use only products. These products are subject to the same regulatory requirements as any unapproved medical device”).
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XTalks
JUNE 27, 2022
CerTest Biotec specializes in the development and manufacturing of in vitro diagnostic medical devices and has expertise in the detection of human diseases. In a joint press release , the companies said the aim of the partnership is to design a diagnostic test that can help advance understanding of the global spread of the disease.
XTalks
JANUARY 21, 2025
From non-invasive cancer diagnostics to life-saving cardiovascular implants, the latest medical devices cleared or approved by the FDA in 2024 reflect the remarkable strides in science and engineering. In this blog, we discuss some of these new medical devices of 2024 that have improved patient outcomes and enhanced quality of life worldwide.
The Pharma Data
OCTOBER 23, 2020
In addition, an international shortage of reagents is looming on the horizon. Our rapid test – in other words, patient-oriented in-vitro diagnostics – can help here” For the new antigen test, a swab from the mouth or nasopharynx is taken by medical personnel. The high quality has been repeatedly verified. NADAL® Covid-19.
XTalks
APRIL 22, 2022
Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. Flow cytometric receptor occupancy assays are being increasingly used in preclinical and clinical studies. What is Flow Cytometry?
FDA Law Blog
SEPTEMBER 21, 2022
This policy and the EUA templates mirror the approach taken by FDA for COVID-19. With COVID-19, CDRH was forced to “build the plane while flying it,” in that it had to create the administrative infrastructure and related guidance and templates while simultaneously issuing the first round of EUAs. The policy also addresses serology tests.
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