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 started an internal process to decide on the regulatory pathway for application for U.S. market acceptance. The company expects to complete its review and reach a decision by 3Q17.
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...
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 started an internal process to decide on the regulatory pathway for application for U.S. market acceptance. The company expects to complete its review and reach a decision by 3Q17.
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