Tag Archives: FDA compliance

Is Your Product Still an FDA-Regulated Device in 2026?

The Answer Might Surprise You. One of the most common questions we have received from manufacturers, software developers, and startup founders this year is: Is my product still considered a medical device by the FDA?" The short answer is: maybe not—but don't assume. In 2026, the FDA continued refining its approach to certain low-risk health

Avoiding FDA regulatory issues in your device development

Why Medical Device Startups Struggle With FDA Regulatory Approval: 10 Common Mistakes Quick Answer Medical device startups most often fail to reach market on time because they treat FDA regulatory compliance as a final step rather than building it into product design from the concept stage. The 10 most common causes of medical device startup

The Mid-Year FDA Compliance Check: 5 Things to Verify Before Q3

Short answer: Before Q3 begins, medical device companies should verify five key compliance areas: FDA establishment registration, QMSR implementation, inspection readiness, U.S. Agent designation (for foreign manufacturers), and the status of any open FDA 483 corrective actions. Addressing these items now can help avoid compliance issues and last-minute challenges during the October registration renewal period.