Hi Amund, Yes, and it depends on the power of the laser and the complexity of the product. The requirements are more stringent for higher power lasers. An initial product report must be submitted to FDA for each laser product and it can take some time to put that together depending on the complexity of the product. I recall there are some standard templates available somewhere for the reports. There are some basic requirements specified in the regulations that must be met and described in the report such as interlocks if applicable and labeling.
Presumably most folks are reporting on a product that includes a laser rather than the actual laser. This simplifies things a bit as you can rely on the OEM documentation for some items and refer to their accession number assigned to their reports. Like everything else there are consultants that specialize in creating the FDA reports. You must submit an annual report due Sept 1 each year describing the production volume of each product and any product issues or complaints that may have been received. The annual report doesn't take much time assuming you are collecting the information throughout the year. -Dave On Tue, May 19, 2020 at 4:16 AM Amund Westin <[email protected]> wrote: > Anyone who have been through the process for complying to 21 CFR § > 1040.10? > Time consuming process? > > BR > Amund > > - > ---------------------------------------------------------------- > 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: > http://www.ieee-pses.org/emc-pstc.html > > Attachments are not permitted but the IEEE PSES Online Communities site at > http://product-compliance.oc.ieee.org/ can be used for graphics (in > well-used formats), large files, etc. > > Website: http://www.ieee-pses.org/ > Instructions: http://www.ieee-pses.org/list.html (including how to > unsubscribe) > List rules: http://www.ieee-pses.org/listrules.html > > For help, send mail to the list administrators: > Scott Douglas <[email protected]> > Mike Cantwell <[email protected]> > > For policy questions, send mail to: > Jim Bacher: <[email protected]> > David Heald: <[email protected]> > - ---------------------------------------------------------------- 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: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]>
