Approaching FDA ahead of formal premarket submission can make the regulatory process smoother for medical devices. But deciding the best moment to make contact requires careful consideration. Medical device companies often want to find out the type...

What’s the best way to go about obtaining FDA authorization to market a medical device? This is the million-dollar question frequently put to us at TSG. Naturally, every situation is different, but the single most important factor is a regulatory...

FDA’s legal and regulatory framework The definition of a medical device FDA’s risk-based classification of a device Paths to market for medical devices 3 primary types of premarket submissions 510(k) premarket notifications De Novo requests...