FDA Requirements for Animal Laboratory Testing (Harmonic Scalpel)

[NicoleinFlorida]

Hello cove,

My company would like to perform an animal lab for our new product, a harmonic scalpel. I am wondering whether FDA has requirements about the animal lab protocol or is there any guidance that I can refer to. This is very new for me. I don't know where to start.

Thank you.

 

[bjohnsonrli]

Hi Nicole,

The FDA has published a draft guidance on evaluating and reporting animal studies for medical devices.

Take a look here:

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM466358.pdf

Regards,

Bryan