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knc1 · 10-13-2014, 01:17 PM

That only applies to sales to people who **use** the device.

Not to those in the Biomedical Instrumentation industry for purposes **other than** use of the device.

Did you have a prescription for every device in front of you the past 20 years?
I bet not.

That is:
Both of us fall under the section 801.109(a)(1)(i) exemption.
http://www.accessdata.fda.gov/script...cfm?fr=801.109

Yup - I have read it before.
My first (engineering) job in the BioMedical Electronic Instrumentation field was in 1972.
(My Avatar is a self photo.

)

10-13-2014, 01:17 PM	#10
knc1 Going Viral Posts: 17,212 Karma: 18210809 Join Date: Feb 2012 Location: Central Texas Device: No K1, PW2, KV, KOA	That only applies to sales to people who use the device. Not to those in the Biomedical Instrumentation industry for purposes other than use of the device. Did you have a prescription for every device in front of you the past 20 years? I bet not. That is: Both of us fall under the section 801.109(a)(1)(i) exemption. http://www.accessdata.fda.gov/script...cfm?fr=801.109 Yup - I have read it before. My first (engineering) job in the BioMedical Electronic Instrumentation field was in 1972. (My Avatar is a self photo. ) Last edited by knc1; 10-13-2014 at 01:51 PM.