Form 3514 CDRH Premarket Review Submission Cover Sheet

J

JayFu

Registered
#1
#1
Has anyone noticed that the current version of the Form 3514 (8/20) gives you only 2 lines to list the SDO, standard number and title? This is totally not enough room for some long-winded names of some standards, for example:
ISO 10993-18:2020
Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
Do you all just leave the title partial and cut off? Or do you make your own Word document of standards and append it to the form?
 
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shimonv

shimonv

Trusted Information Resource
#2
#2
You can just write: "ISO 10993-18:2020 Part 18: Chemical characterization of medical device materials within a risk management process".
 
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