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Category Archives: FDA Updates

25 Jan

New devices added to the device discontinuance list.

FDA Update 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

14 Jan

FDA Update – Recap of 2020

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

23 Dec

FDA Update – FDA Warns Companies Illegally Selling CBD Products

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,

Dec

FDA Update – Human and Animal Food Facilities Biennial Registration Renewal

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

30 Nov

FDA Update – FDA launces new program to support use of Novel Drug Development Tools

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

Nov

FDA Update – Voluntary Qualified Importer Program Update

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;

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