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
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
FDA Update – June 30, 2020 This is an informational notice The FDA requests your input for the 21st Century Cures Act Report On December 13, 2016, the Cures Act was signed into law. This was designed to help accelerate medical product development and bring innovation and advances to patients who need it faster and
COVID-19 – FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk This information is not surprising. During the times of consumer and govt panic, there will always be companies trying to take advantage of situation. The FDA tries their best to keep on top of the situation to
COVID-19 – Guidance on Formal Meetings and User Fee Applications Due to the COVID-19 public health emergency, the FDA has released a new guidance document titled “Effects of the COIVD-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices – Questions and Answers.” The reason for this guidance is to address
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