Are you looking to introduce a new cosmetics product? If so, you may need to have it cleared by the Food and Drug Administration (FDA) and there is also the possibility that it may be regulated as a drug. This will depend on whether the cosmetic is aimed at diagnosing, curing, mitigating, treating, or preventing...Read More

Part of maintaining FDA compliance is ensuring that you’re taking all of the necessary precautions and steps to be compliant in the event of an FDA inspection. Where others have run into violation issues, you can avoid making these same mistakes by being aware of some of the most common violations and employing the steps...Read More

The Food Safety Modernization Act (FSMA) signed into law back in 2011 allows the FDA to regulate how foods are grown, harvested, and processed. Among its powers, the FDA can issue a recall if necessary. Hence, you must comply with the FSMA and its various rules.Food facilities are mandated by the FDA’s Preventive Controls Rules...Read More

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...Read More

A labeler is identified by the FDA as any entity that causes a label to be attached to a product to commercially sell the device without any subsequent substitution or alteration of the label.Also…An individual who causes the label of a product to be replaced or altered to sell the device commercially without any resultant...Read More

Previously we talked about medical device registration, Today, we’re sharing some insight on the human drug products process. The first thing you’ll need to do is obtain a DUNS number. If the drug product is finished and under OTC monograph, you can proceed to the labeling. If it is not under OTC monograph, then you...Read More

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,...Read More

Beneath the U.S. The Food Traceability Proposed Rule of the FDA can require people who grow, package, process, or store food on the Food Traceability List (FTL) of the FDA to control and record Key Data Elements (KDEs) at Critical Tracking Events (CTEs). Some of the foods that can be found on the FTL include...Read More