The FDA is alerting clinical laboratory staff and health care providers of a risk with Thermo Fisher Scientific TaqPath COVID-19 Combo Kit, which is a molecular assay for detection of COVID-19 from respiratory specimens. The risk is of false results based on two issues. The first being related to inadequate vortexing and centrifugation of RT-PCR
By Alan Schwartz YES, there will be a day when the US EUA, Emergency Use Authorization Act, will be lifted, the medical device industry goes back to reality and the FDA regains control of the medical approval process with the “a REAL” device review in place. In my almost 5 decades of FDA experience, this
FDA Regulation of Artificial Intelligence/ Machine Learning in Medical Devices Introduction The use of Artificial Intelligence/ Machine Learning (AI/ML) will revolutionize medical devices by making them more efficient and improving their performance. AI/ ML can be defined as “techniques used to design and train software algorithms to learn from and act on data received from
How do manufacturers of a new medical devices determine what is the best price for their product? The typical method is to look for similar products in the marketplace and arrive at a price which will be competitive. However, there are certain circumstances that will allow you to set a higher price based on what
FDA MedWatch Alert – July 14, 2020 Hand Sanitizers by 4e Brands North America: Recall Due to Potential Presence of Undeclared Methanol (Wood Alcohol) The company 4e Brands North America, based out of San Antonio, Texas, issued a nationwide voluntary recall of hand sanitizer due to the potential presence of undeclared methanol (wood alcohol) on
FDA Update – July 13, 2020 COVID-19 Update – FDA prepares for resumption of domestic inspections with new risk assessment system As a follow up to the update of July 10 on this item we have broken out some of the more critical areas on the FDA On-Sight Inspectional restart. The FDA is working towards
FDA update July 10, 2020 Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system You may not have been aware but the FDA has halted all in plant inspection since March because of the COVID-19. Well, unfortunately for industry, All Good Things Must Come to an END. The FDA
FDA Update – July 9, 2020 Updated Q&A Appendix for guidance Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency This is some interesting information on problems companies had conducting clinical trials during this Pandemic Crisis. The FDA made a recent update to the guidance document titled Conduct of Clinical Trials of
FDA Update – July 8, 2020 False Positive Results with BD SARS-CoV-2 Reagents This will probably not be the last of these types of notices. The FDA is alerting clinical laboratory staff and health care professionals of increased risk of a false positive result with BD SARS-CoV-2 Reagents for the BD Max System test. In
FDA Update – June 30, 2020 FDA Issues Guidance Regarding Compliance Dates for Unique Device Identification Requirements On June 30, 2020, the FDA issued the guidance Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking for immediate effect. The unique device identification (UDI) system is
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