PMTA Deficiencies: The Most Common Reasons Applications Stall
August 25, 2026 Written by Austin Tyner Clinical [...]
Human Factors Is Now a Checkpoint in Every Device Submission
August 19, 2026 Written by Eric Jacobson Regulatory [...]
De Novo Classification: When It’s the Right Path and How It Works
August 5, 2026 Written by Austin Tyner Clinical [...]
Navigating the FDA 510(k) Process: A Step-by-Step Guide to Substantial Equivalence and Avoiding Common Pitfalls
July 28, 2026 Written by Austin Tyner Clinical [...]
FDA Authorizes PMTA for First Flavored ENDS Products Other Than Menthol and Tobacco
May 5, 2026 Yesterday, the U.S. Food and [...]
Industry Insight: What is Breakthrough Device Designation for Medical Devices?
What is the Breakthrough Device Program? The FDA’s Breakthrough [...]
FDA Stalls Nicotine Pouch Fast-Track Program Over Youth Adoption Concerns
On April 1, a report by Reuters stated that [...]
FDA Granted Regulation of Synthetic Nicotine: What You Need to Know
FDA Granted Regulation of Synthetic Nicotine: What You Need [...]
Don’t Just Win a PMTA Battle, Win the PMTA War
Don't Just Win a PMTA Battle, Win the PMTA War [...]
New Bill Aims to Regulate Synthetic Nicotine in 2022
New Bill Aims to Regulate Synthetic Nicotine in 2022 [...]
