FDA requires you provide test data so if using a standard and you or your company is not an expert in it and doesn't have the proper calibrated test equipment that is the best way to go but it is not mandated by the FDA. This is my area of expertise so if you need some support please feel free to contact me.
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Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email:
Leo@EisnerSafety.comWebsite:
www.EisnerSafety.com------------------------------
Original Message:
Sent: 25-Jul-2019 13:06
From: Anonymous Member
Subject: ETL/UL Certification
This message was posted by a user wishing to remain anonymous
Is the ETL/UL certification required by the FDA for medical devices?