US FDA Premarket Approval: Your Comprehensive Guide
FDA has three types of regulatory pathways, namely 510(k), De Novo, PMA, for medical device approval. US FDA premarket approval (PMA) is the most rigorous and stringent regulatory pathway. High-risk devices (Class III devices that sustain life or pose significant...
Mistakes in FDA Device Approval Submissions & How to Avoid Them
To launch your medical device in US, you will require FDA medical device approval. Broadly classified there are three types of FDA regulatory pathways, namely 510(k), De Novo, PMA, for FDA medical device approval. It is important to choose the correct regulatory...
Differences Between Substantial Equivalence and Predicate Device
Identifying the correct predicate device is the first critical step in US FDA 510(k) submission. The FDA authorities evaluate whether your device is substantially equivalent to the predicate device you have mentioned in the application. If it is equivalent, then your...