Top Reasons 510(k) Submissions for Dental Devices Get Rejected (And How to Avoid Them)
Few things set back a product launch more painfully than a rejection letter from the FDA. When your 510(k) submission
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May 10, 2026
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[blog_list]
How to Get GRAS Status for an Extract: What the Process Actually Involves
Pursuing GRAS status for an extract is not the same as pursuing it for a whole botanical or a well-characterised food ingredient. The
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May 3, 2026
What to Do (and Avoid) in Your FDA 510(k) Submission Process
Getting an FDA 510(k) submission right the first time is one of the most consequential steps in your medical device’s path to market.
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April 13, 2026
Weight Loss Supplements and FDA Rules: What Every Brand Needs to Know Before Going to Market
Weight loss supplements are one of the most commercially attractive categories in the dietary supplement industry, and one of the
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April 10, 2026
How to Build a Medical Device QMS That Meets FDA QMSR Requirements
If your organization sells finished medical devices in the United States, the structure of your medical device QMS is no
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March 9, 2026
Time to Renew: FDA Drug Establishment and Listing Deadline Is Coming Up
If your company manufactures, repacks, relabels, or imports drugs for distribution in the U.S., it’s time to prepare for the
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October 23, 2025
Navigating FDA and Health Canada Rules for Eczema Products
The eczema product market continues to grow as consumer demand increases, but that doesn’t mean you can jump in without
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May 6, 2025
Self-Affirmed GRAS May End – What It Means for You
The self-affirmed GRAS pathway may soon be eliminated. On March 10, 2025, HHS Secretary Robert F. Kennedy Jr. directed the
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March 12, 2025
GRAS in Pet Food: A Guide to Ingredient Compliance
GRAS in pet food – these four words can make a big difference in your product’s regulatory status. Understanding what
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February 5, 2025
A Practical Compliance Guide to Shilajit and FDA Rules
Navigating the FDA compliance process for shilajit can be challenging, especially if you’re new to the regulatory landscape. As shilajit
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January 24, 2025
FDA Sets 2028 Compliance Date for Food Labels
The U.S. Food and Drug Administration (FDA) recently announced a uniform compliance date for food labeling regulations. This update establishes
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January 10, 2025
How Drug Registration Works in the U.S. and What NDC Numbers Mean
Drug registration and NDC number might sound technical, but they play a big role in how medications make it to
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October 4, 2023
10 Steps to Sell Dietary Supplements in the U.S.
The dietary supplement industry in the U.S. is growing fast. More people are looking for vitamins, minerals, and other supplements
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September 14, 2023
How the GRAS List Works for Food Additives
If you’re in the food business, you’ve likely come across the term “GRAS”, short for “Generally Recognized as Safe.” It’s
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June 20, 2023
5 Tips to Find the Best Medical Device Regulatory Consultant
Finding the right medical device regulatory consultant is one of the most important steps to ensure your product meets all
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February 15, 2023