The Essenvia Blog

Our goal is to provide the guidance, industry updates and information you need before submitting your next 510(k) application to the FDA.

5 Reasons You Shouldn't Submit Your 510(k) Application Alone

Our top 5 reasons why you should not try to submit a 510(k) application alone and how our program will provide the guidance and relevant information you require.

The Top 5 Reasons The FDA Rejects A 510k Submission

The most common reasons the FDA rejects 510(k) submission applications and the steps you can take to submit as close to rejection proof application as possible.