On September 23, 2020, mdi Consultants successfully obtained EUA authorization for our client Jiangsu Well Biotech Co., Ltd.’s “Orawell IgM/IgG Rapid Test”. This is only the 16th rapid antibody test authorized by the FDA to identify the presence of both IgG and IgM antibodies since the EUA period began in March, 2020. Throughout the FDA review
mdi predicated that the FDA would be closing these EUA down as soon as there are enough supply on the market. (https://mdiconsultants.com/life-after-the-eua/) The FDA monitors the 510(k) activity as we as the importing supply. The FDA has also been contacting companies to determine the amount of supply of various devices. This is the history of
The FDA has recently been made aware of potential adverse health effects of mercury exposure with the use of dental amalgam to certain groups. This is due to the mercury vapor (gas) released from the dental amalgam fillings. These groups include: Pregnant women and their developing fetuses; Women who are planning to become pregnant; Nursing
Tuesday, September 15th, 2020, the FDA published comparative performance data for some authorized COVID-19 molecular diagnostic tests. The tables show the Limit of Detection (LoD) of more than 55 authorized molecular diagnostic COVID-19 tests against a standardized sample panel provided by the FDA. The FDA provided these standardized samples, known as a reference panel, to
The FDA is notifying companies involved in research containing cannabis and cannabis-derived compounds of the benefits of using Drug Master Files (DMFs). These files are submissions to the FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. Companies are able
mdi has been assisting clients in getting their medical devices licensed for Canada through the Health Canada offices. Many clients are now looking to see how they can get their medical devices to market faster using the Interim Order for Health Canada. This is the information that we have come up with for using the
The EUA is causing havoc in the medical industry and for the FDA. Now there is a gown that does not meet specification and the FDA is warning on it discontinued use. The faster the FDA can stop this EUA the faster the FDA can get a better control on these PPE products and manufacturing
Protective Barrier Enclosures Without Negative Pressure Used During the COVID-19 Pandemic May Increase Risk to Patients and Health Care Providers As the FDA learns more about what is effective and what isn’t or possibly harmful for the treatment of COVID-19, they make adjustments. Here is an EUA that they issued for a medical device back
As we have learned during these “EUA” times and lack of FDA oversight on new companies manufacturing and selling various products during this pandemic, there are some very serious situations of adulterated products. The FDA is trying hard to monitor this situation and address critical issues as they pop up. The FDA’s investigation of contaminated
The FDA is warning consumers about certain hand sanitizer products, including those manufactured by Harmonic Nature S de RL de MI in Mexico, that are labeled to contain ethanol or isopropyl alcohol. After testing, they have proven to be contaminated with 1-propanol contamination. 1-propanol, not to be confused with 2-propanol/isopropanol/isopropyl alcohol, is a toxic and
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