New devices added to the device discontinuance list. The FDA is constantly reviewing their emergency use list. As we have been writing and warning that as the amount of needed products come to market via the EUA and 510(k) the FDA will discontinue the items. Companies should be away that they will need to have
Since the beginning of the pandemic, the FDA has been in observation of reports of serious adverse events related to ingestion of alcohol-based hand sanitizers. The FDA has also received numerous reports of dermal toxicity associated with these products. In the Spring 2020, FDA discovered a few hand sanitizer products that were labeled to contain
Over the past 10 months mdi has been actively assisting numerous companies with the EUAs for Masks, Gowns and Gloves as well as the Covid 19 tests. Several of our clients are included in the numbers provided by the FDA below. To look back on 2020, the FDA has released an infographic providing visualization of
The FDA is warning consumers not to use close to 50 male enhancement or weight loss products. These products have been found to contain hidden ingredients and may pose health risks. Products were purchased by the FDA through Amazon and eBay and testing found active pharmaceutical ingredients not included on the label. Some of these
We have been warning clients on the use of CBD and the FDA regulatory requirements. You need to be very careful on the claims you want to make on your products that contain CBDs. Here is some recent FDA actions. The FDA has recently issues 5 warning letters to companies for violating Federal Food, Drug,
REMINDER FDA Update – Human and Animal Food Facilities Biennial Registration Renewal The FDA is reminding human and animal food facilities about this year’s biennial registration renewal period. These facilities, domestic and foreign, are that required to register with the U.S. FDA must renew their registration this year before December 31. The FDA will consider
The FDA has issued the guidance document, Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency, because the agency recognizes that the public health emergency caused by COVID-19 has impacted the conduct of clinical trials of medical products, including drugs, devices, and biologics. These challenges may arise from isolation practices, site closures,
The FDA has just launched a new program, the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program. This program is meant for developers of novel drug development tools (DDTs), allowing pathways for those developers to submit proposals for novel approaches that are currently without an existing regulatory path. The existing DDT qualification
If you are unaware of the Voluntary Qualified Importer Program (VQIP), it is a voluntary fee-based program that allows for expedited review and import entry of food for humans and animals into the United States under the FDA Food and Safety Modernization Act (FSMA). The FDA has recently just approved 3 participants into this program;
Could this be the start of the FDA rescinding the EUAs? On October 15, 2020, the FDA reissued the EUA for certain filtering face-piece respirators (FFRs) manufactured in China which are not approved by the CDC’s National Institute for Occupational Safety and Health (NIOSH). The agency is reissuing this EUA to authorize only those types
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