FDA Submission

OIG: FDA recommendations for future pandemics
OIG offered numerous recommendations to manage such infectious disease emergencies, saying the FDA should access and, when appropriate, revise its guidance for Emergency Use Authorization (EUA) submissions for tests.
September 21, 2022
2021 11 29 23 50 3003 Fda Button 20211129235739
Cue Health requests FDA de novo clearance for at-home flu test
Clearance would permit the test to be used at home and elsewhere at the point-of-care (POC).
September 1, 2022
2022 09 02 19 52 9683 Flu Season Ahead 400
FDA issues updated reagent, instrument guidance
The agency said that it revised the current guidance to include point-of-care in vitro diagnostic (IVD) devices in certain situations, flowcharts, updates to examples, and further clarification of terminology.
August 15, 2022
2021 11 29 23 50 3003 Fda Button 20211129235739
Natera files presubmission with FDA for NIPT test
According to the FDA, Q-Subs can serve as helpful tools in the premarket submission process.
August 10, 2022
2019 10 09 23 45 4810 Lab Nipt Test 400
Abionic nabs IVDR certification for sepsis test
The device detects pancreatic stone protein, an early marker for sepsis, allowing for its identification in about five minutes, Abionic said.
August 8, 2022
2020 06 19 20 57 0712 Sepsis Bacteria 400
I-calQ receives 9th patent for smartphone POC testing
I-calQ's technology uses the smartphone as a processor. Its camera is used to read a disposable test strip cassette, and a proprietary app that analyzes, calibrates, and quantifies results in about 10 minutes. It also has the ability to upload the data immediately.
January 14, 2021
2020 03 04 00 35 9478 Smartphone Hands 400
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Genetic causes identified for three rare diseases
Researchers in study validate test to identify newborns with homocystinuria, a rare inherited disease
SARS-CoV-2 infection weakens immune-cell response to vaccination, study suggests
Duke University researchers discover biomarkers may identify early pancreatic cancer risk
Chembio CEO urges stockholders to tender remaining shares as deadline is extended for acquisition
Cue Health Q4 revenues decline 24% as firm expands, diversifies POC test menu
MDIC releases IVD regulatory decision-making framework
The framework is designed to help the IVD industry and the U.S. Food and Drug Administration (FDA) better incorporate real-world data into development and regulatory decisions for IVD products. It also outlines the designs and statistical methods needed in order to generate real-world evidence for regulatory submissions.
August 23, 2020
2019 07 26 20 46 7792 Lab Blood Woman 400
HHS: FDA review not needed for coronavirus LDTs
In the guidance, the HHS said that the FDA will not require labs to go through premarket review of LDTs for COVID-19 before they can be used on patients. Labs can choose to seek emergency use authorization (EUA) from the FDA if they wish, and the agency will adjudicate these submissions.
August 19, 2020
2020 01 27 21 38 4451 Lab 2019 Coronavirus Test 400
Abbott unveils lab-based COVID-19 antibody blood test
The IgG antibody test will be available initially on Abbott's Architect i1000SR and i2000SR laboratory instruments, which can run up to 100-200 tests per hour, according to the vendor. The firm is also working to add the test to its new Alinity i platform.
April 15, 2020
2020 04 15 22 01 4693 Abbott Architect 400
Myriad files companion BRCA test in prostate cancer
The test detects and classifies variants of BRCA1 and BRCA2 genes in whole blood specimens. An application for Lynparza, which is a poly (ADP-ribose) polymerase inhibitor marketed by AstraZeneca and Merck, in the second-line treatment of metastatic castration-resistant prostate cancer (mCRPC) with suspected deleterious germline or somatic gene mutations has been accepted by the FDA. The filing has priority review with the agency, and a user fee date has been set for the second quarter.
January 20, 2020
2020 01 21 20 56 1476 Document Submission 400
FDA moves to electronic-only device submissions
The rule, which aims to improve the agency's efficiency, was issued on December 13. The administration plans to publish a revised "eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff," which will reflect the amendments to the regulations.
December 12, 2019
2016 09 02 09 36 05 93 Fda Logo V2 400
FDA airs 'to do' list for devices in 2020
The agency's Center for Devices and Radiological Health (CDRH) released its list of planned new guidance documents, with some prioritized for next year, along with a request for input on whether certain older guidance documents should be changed or withdrawn.
October 13, 2019
2019 02 13 19 24 5396 Fda Logo V2 400
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