Glue Record and Traceability according FDA Requirements

Hi all,
does somebody know, if there is any requirement according FDA to have the record about used glue in the product (LOT/Batch/expire date), or is there enough to have the procedure describing to check the expire date of the glue before the use?
Thank you!

Re: Glue record and traceability according FDA

Everything depends on the product classification and intended use criticality, and the criticality of the procedure and materials in question.

If you're making very high value life safety implantables, you probably want to have extremely detailed work processes with step signoffs and traceability for all of your materials, so that if you have a failure you can possibly provide information to physicians that will save lives, and so that you can avoid recalling every unit you ever made.

If you're making a non-patient-contact Class I device, it doesn't matter as much.