In-Vitro Manufacturing Reagent 
XTalks
JANUARY 21, 2025
TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Abbott Spinal Cord Stimulation (SCS) Systems Manufacturer/developer : Abbott Medical Date of FDA approval : May 30, 2024 Approved for : Chronic, hard-to-manage pain in the torso, arms and legs.
FDA Law Blog
NOVEMBER 1, 2023
Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
The Pharma Data
MARCH 23, 2022
We are also donating reagents and consumables for automatic testing of up to 120,000 blood donations and 31,000 units for diabetes management. This latest donation demonstrates our commitment to meeting the need for Roche medicines and diagnostics in Ukraine whenever possible. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
The Pharma Data
DECEMBER 14, 2020
Description of the problem : WHO has received user feedback on an elevated risk for false SARS-CoV-2 results when testing specimens using RT-PCR reagents on open systems. . Manufacturers regularly review the design of their product, including labelling and IFU based on customer feedback.
FDA Law Blog
SEPTEMBER 21, 2022
The monkeypox test policy describes how FDA will prioritize review of EUA requests for monkeypox tests, stating that FDA intends to focus on requests for high-throughput tests, tests with home specimen collection, or rapid diagnostic tests, all from experienced developers with high manufacturing capacity.
FDA Law Blog
OCTOBER 6, 2023
The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. There is much to unpack, and we intend to do so in a series of blog posts.
FDA Law Blog
APRIL 19, 2021
The Court decision limiting FDA’s discretion provides regulatory certainty for device manufacturers, as the claimed discretion, if recognized by the Court, would have meant that any medical device potentially could be classified and regulated as a drug. We have blogged recently about several FDA setbacks in court ( here , for example).
Expert insights. Personalized for you.
105 
Let's personalize your content