Episurf Medical Update: US Regulatory Path

In early 3Q16, Episurf Medical participated in a pre-submission meeting with FDA and submitted a 513(g) request regarding classification and regulatory requirements that may apply to the Episealer device.

Feedback now received from FDA is not decisive, and opens various alternatives; further interaction with FDA has been initiated. Episurf has...

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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.

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