Identification and Traceability in Medical Device Tracking - FDA Requirements

[Jimmy Olson]

Seeking information on Identification and Traceability in Medical Device Tracking

Hello again everyone.

There has been a lot of rumblings around here in regards to identification and traceability in regards to FDA requirements. I am curious to know if we would need to apply this to everything we do, or if we can apply it to the specific medical products. We won't be manufacturing anything that would fall into the category of implant or life support, so my understanding is that we don't need lot traceability under the FDA requirements. But I might be off in interpreting that.

Any kind of clarification you can provide regarding identification and traceability would be greatly appreciated. We are currently trying to determine what we need to do and the scale of everything. Thanks.

[Al Rosen]

Hi Richard:

The FDA recently published a document about this subject. You can find it through the following link.

Medical Device Tracking

In general, you can find a lot of what you need at www.FDA.gov/cdrh/

I was thrust into medical devices just over 2 years ago and used the FDA site and their guidance documents for everything. You can do a search there to answer a lot of questions. If you need any additional information or help, let me know.

[Jimmy Olson]

Hi Al,

Thanks for the link, that helped clear things up a bit. I've been to the CDRH site quite a bit, but trying to navigate through everything is a bit of a nightmare at times

I too am being thrust into the medical devices area (although slowly, thankfully). I've been gathering information and trying to interpret everything as I go. One thing that would be handy if you know where I could find it (if it exists) is something that cross references all the FDA regulations. I've been learning that there are a number of regulations that add to or clarify portions of 21 cfr 820. I do have a book on the way that will hopefully help

Thanks again for the information. I was just given the green light yesterday to start doing some heavier and more indepth research to figure out the gaps we would need to fill, so I'm sure I will have plenty of questions soon.

[Al Rosen]

Richard:

Cross referenced to what? The regulation can be found in the Federal Register. Or, try the following link to find title 21 part 820.

http://www.access.gpo.gov/cgi-bin/cf...i?title=200121

I can e-mail you a cross reference to 9k:2k which would also align with 13485:2003. It also identifies requirements not in 9k:2k.

[Jimmy Olson]

I have a couple of cross reference charts that cover 9k2k, 13485, and 820 that are pretty useful, but I would appreciate it if you sent a copy of the one you have (rolson@atscorp.net). The thing I was talking about was if there is something that references 820 to the other FDA regulations that apply (such as section 11 for electonic records, section 821 for tracking, etc...). It seems like I'll read a portion of 820 and understand that, but then find out there are other refulations that apply. I hope I'm making sense

In 9k2k there are notes that refer to other documents (such as for calibration and auditing) to either add or clarify. Basically I was wondering if there was something like that for 820 so I can find out all the regulations that would apply in addition to 820. I might be making this way more complicated than I need to, and if so, please let me know.

[Al Rosen]

Richard:

Try the guidance documents at: http://www.fda.gov/cdrh/guidance.html

or you might find this site helpful
http://www.fda.gov/cdrh/comp/gmp.html

Using calibration as an example, what you need is in the regulation and it's probably what you have covered in your current procedures.

Sec. 820.72 Inspection, measuring, and test equipment.

(a) Control of inspection, measuring, and test equipment. Each
manufacturer shall ensure that all inspection, measuring, and test
equipment, including mechanical, automated, or electronic inspection and
test equipment, is suitable for its intended purposes and is capable of
producing valid results. Each manufacturer shall establish and maintain
procedures to ensure that equipment is routinely calibrated, inspected,
checked, and maintained. The procedures shall include provisions for
handling, preservation, and storage of equipment, so that its accuracy
and fitness for use are maintained. These activities shall be
documented.
(b) Calibration. Calibration procedures shall include specific
directions and limits for accuracy and precision. When accuracy and
precision limits are not met, there shall be provisions for remedial
action to reestablish the limits and to evaluate whether there was any
adverse effect on the device's quality. These activities shall be
documented.
(1) Calibration standards. Calibration standards used for
inspection, measuring, and test equipment shall be traceable to national
or international standards. If national or international standards are
not practical or available, the manufacturer shall use an independent
reproducible standard. If no applicable standard exists, the
manufacturer shall establish and maintain an in-house standard.
(2) Calibration records. The equipment identification, calibration
dates, the individual performing each calibration, and the next
calibration date shall be documented. These records shall be displayed
on or near each piece of equipment or shall be readily available to the
personnel using such equipment and to the individuals responsible for
calibrating the equipment.