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FDA News
Medical Device Reporting (MDR) Step-by-Step Guide for Compliance and Safety Excellence
Medical Device Reporting (MDR) under 21 CFR Part 803 is how the U.S. Food and Drug Administration (FDA) collects reports when a medical...
Sep 256 min read
What Counts as a General Wellness Device—And What Doesn’t
Not every product that promotes health is exempt from FDA regulation. The agency’s General Wellness Guidance outlines what qualifies as...
Sep 82 min read
How To Avoid the Consequences of FDA Regulations on Your Startup?
The FDA began regulating around the time they began to notice that the food and drugs that can sustain us can also be just as dangerous....
Oct 12, 20244 min read
The FDA’s 2nd Medical Device Ban in History
The FDA can be a thorn in the side of many medical device companies. The regulations could make your head spin. However, the FDA has only...
Jul 15, 20222 min read
Need Hand Sanitizer? FDA Has You Covered
We are very proud that our firm is on the front lines helping businesses gain compliance and continue to increase the supply of hand...
Jul 15, 20221 min read
Medical Device Regulation and The De Novo Process
New medical devices and novel uses for them should be celebrated as our world moves to continuously innovate. The FDA has been a driving...
Jul 15, 20222 min read
New Apple Watch Gains FDA Approval
The Food and Drug Administration’s quick approval of the Apple Watch has brought industry scrutiny. Most medical device companies wait...
Jul 15, 20221 min read
Will the Medical Device Industry Benefit from a Trump Presidency?
We have officially elected the 45th president of the United States. What a relief right? I mean this election season has been tumultuous...
Jul 15, 20222 min read
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