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FDA UDIs: How Many Will You Need?

Before we get to the primary topic, you should know that the United States FDA Registration Renewal period closed on December 31, 2020. If your renewal was not processed by the deadline, you are required to go through the FDA re-registration process. Today, we’d like to briefly talk about the number of FDA Unique Device […]

A Quick Primer on Medical Device Registration

Are you looking to register medical devices? If so, there are certain steps you should take to ensure the most straightforward and error-free process. To help you get started, this handy guide may provide some useful information. For starters, you should start by identifying which product class your medical device belongs to: Class one, two, […]

What to Know About FDA Prior Notice

For any imports of food, drinks, and nutritional supplements entering the United States, the Food and Drug Administration (FDA) requires the submission of what’s called Prior Notice. The FDA will release a confirmation number in the form of a barcode following receipt of the Prior Notice, which would accompany the majority of food shipments. Filing […]

Does Your Food Facility Need to Register With the FDA?

The term “food facility” is broad and although many of these facilities must register with the FDA, there may be scenarios or certain facilities that don’t need to register. If you’re having trouble figuring it out, we’re making it easier to determine whether or not it’s required. If your food facility, manufactures, packs, labels, processes, […]

FDA Tweaks Acceptable Facility Registration UFI Guidelines

The FDA released a revised manual earlier this month outlining how to abide by the obligation of the FDA to have a Unique Facility Identifier (UFI) accepted as appropriate by the FDA when requesting registration or renewal of a food facility. The guideline also offers information about what to do should a facility be unable […]