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FDA News
Oct 252 min read
How Small Businesses Can Work Toward FDA Compliance
Starting your own small business can be hard work, but extremely rewarding. Add a major governmental agency like the FDA into the mix and...
Oct 124 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....
Jul 16, 20221 min read
Innovative Covid-19 Screening Device Receives EUA From FDA
Imagine an armband that, combined with special software, can tell you whether there is coagulation in the blood of a patient within 3-5...
Jul 15, 20221 min read
Medical Device Manufacturers Required To Report Shortages During Pandemic
The FDA's CDRH issued guidance, effective immediately, detailing new requirements for medical device manufacturers to notify it of...
Jul 15, 20222 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, 20221 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
Covid-19 At-Home Test Kits Coming Soon!
Although this is not in production for personal use just yet, this FDA emergency use authorization (EUA) gives us hope that we will be...
Jul 15, 20221 min read
FDA Authorizes A COVID-19 Test That Will Take Hours, Instead of Days
Lately, there is more than enough bad news to go around, but FDA's recent Emergency Use Authorization may provide some good. The most...
Jul 15, 20222 min read
Can N95 Respirators and Surgical Masks Protect You from Coronavirus?
The FDA is weighing in on this very real dilemma hitting the public sphere. The coronavirus is spreading quickly, and many consumers are...
Jul 15, 20222 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, 20221 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, 20222 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...
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