Or according to the FDA's Regulations, what kinds of capability should a traceability system be reached?

For example, should we keep the concession information of raw material in the DMR?

Thanks :notme::notme::notme:

Is your inquiry in regard to Traceability per 21 CFR 820.65, or Device Tracking per www.fda.gov/cdrh/devadvice/353.html (http://www.fda.gov/cdrh/devadvice/353.html) and 21 CFR 821, or general operations with critical raw materials that are obtained in batches and are known to have a potential for significant batch-to-batch variation?

Or according to the FDA's Regulations, what kinds of capability should a traceability system be reached?

For example, should we keep the concession information of raw material in the DMR?

Thanks :notme::notme::notme:

Traceability, as mentioned by MIREMGR is covered by 21 CFR 820 under Sec. 820.65 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1&subpartNode=21:8.0.1.1.12.6) and states as below -

Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user shall establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components. The procedures shall facilitate corrective action. Such identification shall be documented in the DHR.

So going back to your earlier question, all concerns with the raw material (incl Material review Board recommendations) should be part of Device History Record (DHR).

Or according to the FDA's Regulations, what kinds of capability should a traceability system be reached?

For example, should we keep the concession information of raw material in the DMR?

Thanks :notme::notme::notme:

Welcome,

I am assuming that you are still new and will guide you through our search feature. Just go to search, then advance search and key in 'fda + traceability' as key words and you will get the following:

Identification and Traceability in Medical Device Tracking - FDA Requirements (http://elsmar.com/Forums/showthread.php?t=6292&highlight=fda+traceability)

Procedure on Traceability - FDA audit finding (http://elsmar.com/Forums/showthread.php?t=28091&highlight=fda+traceability)

Thanks a lot for all of your answers.