12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2015)

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

Thank you Ajit. The article does mention ICCBBA as an FDA accredited issuing agency. Their focus appeared to me to be inappropriate for non-tissue-containing devices; that is why I said what i said. I could be wrong about that. I will research further and update the article to clarify what I mean. Thanks again and stay tuned.

Here is a link to the ICCBBA website for those who are interested.

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

Believe it or not, I thought about the World Series analogy.
So far, the baseball world series has never been "played" in Canada - or has it?
Hmmm...not sure...Montreal and Toronto have had teams from time to time...but I don't recall them making it to the big game - could be wrong.

Good idea regarding adding a software FAQ - I will consider that and repost if I make an update.

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

Sam Lazzara said:

Thank you Ajit. The article does mention ICCBBA as an FDA accredited issuing agency. Their focus appeared to me to be inappropriate for non-tissue-containing devices; that is why I said what i said. I could be wrong about that. I will research further and update the article to clarify what I mean. Thanks again and stay tuned.

Here is a link to the ICCBBA website for those who are interested.

Click to expand...

Thanks Sam, I didnt knew about it and will wait for your updates

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

It was quite useful. Do u have specific macro level FDA check list can u able to share.

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

Anyone else marketing devices under their Facility Name instead of their Owner/Operator Name, with the Facility Name being a (legally registered) d/b/a, and unsuccessful so far in getting GS1 to create an account for that marketing name, i.e. Facility Name?

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

Hi All

First, Thanks Sam for your helpful advice! This has been a great thread.

I've been working my way through FDA 21 CFR to determine if any of our products are eligible for exemption.

I have worked my way to 801.30 (10) which talks about exemptions for a device for which FDA has established a performance standard and has provided therein an exception from the requirement of ?801.20.

My devices have Performance Standards. Some of the performance standards quote:

and some add in 801, ie

I am wondering if the omission of part 801 from the first example could be considered to mean that it is exempt from the UDI requirements even thought there isn't an explicit exemption as inferred by Part 801.30 (10).

Any one have any opinions on this?

Cheers

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

Please provide FDA Product Code

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

GEX and HQF

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

MIREGMGR,
Are you saying that GS1 is looking to verify that the company name in your application matches the Owner/Operator Name in your FDA establishment registration? Otherwise they do not let you join? If so, that is news to me.

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

medgar,
Short answer to your question - Yes, I have an opinion. Long answer is below.

Lasers are not in my wheel-house but reading and interpreting convoluted regulations is a hobby of mine.

FDA regulates more than medical devices. They also (for example) regulate radiation-emitting products such as laser products.
Here is the link that addresses Performance Standards for such products.

At the bottom of that page you should see this:
Medical Devices - Electronic Products that are also Medical Devices are subject to the device provisions of the Federal Food, Drug, and Cosmetic Act.
This statement creates a dividing line between radiation-emitting product Performance Standards from those related to medical devices.
In fact, for medical devices I believe that FDA has issued only one (1) Mandatory Performance Standard over the many years since the concept was invented.

?801.20 (Label to bear a unique device identifier) came into effect for the first time on 2013-09-24.
It is unlikely that any FDA medical device Performance Standards have been issued since 801.20 came into existence. Even so, they would need to explicitly mention exemption from 801.20 UDI requirements.

When I went here and here to check out your Product Codes I found that there are no "Performance Standards" listed.
Both devices are Class 2 and not exempt from GMP (21 CFR 820).
Also, in both cases there are Recognized Consensus Standards and Guidance Documents listed.

Check out Cover Letter item 10 on this page.
It says this:
Only one FDA mandatory performance standard exists for medical devices under section 514. Manufacturers of electrode lead wires and patient cables must conform to the standard set forth in 21 CFR 898.
If your device emits ionizing, non-ionizing, sonic, or light radiation, performance standards may exist for the radiation emitting device under RCHSA.

Hope that "helps".