I have been asked about the requirements for submitting an FDA 2877 DECLARATION FOR IMPORTED ELECTRONIC PRODUCTS SUBJECT TO RADIATION CONTROL STANDARDS, for a laser used as a light source for microscopy. The goal is to use the exemption under 21 CFR 1020.50 (a) 3, "Used by trained individuals for research.”
As I have not done one of these submissions before, if you have experience with this I would be open to referring the work to you. If you are willing to get me up on the topic, that would work too. Thanks in advance to all who respond. Doug Nix [email protected] +1 (519) 729-5704 - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]> All emc-pstc postings are archived and searchable on the web at: https://www.mail-archive.com/[email protected]/ Website: https://ewh.ieee.org/soc/pses/ Instructions: https://ewh.ieee.org/soc/pses/list.html (including how to unsubscribe) List rules: https://ewh.ieee.org/soc/pses/listrules.html For help, send mail to the list administrators: Mike Sherman at: [email protected] Rick Linford at: [email protected] For policy questions, send mail to: Jim Bacher: <[email protected]> _________________________________________________ To unsubscribe from the EMC-PSTC list, click the following link: https://listserv.ieee.org/cgi-bin/wa?SUBED1=EMC-PSTC&A=1
