US FDA Unique Device Identification (UDI) Proposed Rule

sreenu927

Quite Involved in Discussions
#1
Hi All,

US FDA has released a proposed rule on Unique Device Identification (UDI). It’s scheduled to be published in the Federal Register next week, but can be viewed from the link provided in the FDA website (also I hv attached here).

A link to FDA’s page on UDI is here

http://www.fda.gov/MedicalDevices/D...Identification/default.htm?source=govdelivery

The GHTF issued UDI system recommendations in 2011, emphasizing the use of global standards so that UDI data can be shared across medical device markets.

Also, you might be aware the IVD Directive is going to be a "Regulation" soon with changes implemented somewhere in between 2014-2015, also have some information on implementation of UDI.

I am not sure, whether the proposed FDA UDI system has incorporated those GHTF recommendations or not, as it is 165 pages, I didn't go through the document.

You can submit your comments, if any on this.

Regards,
Sreenu
 

Attachments

Elsmar Forum Sponsor
G

Gert Sorensen

#2
It is going to be very interesting to see if this is going to be the trendsetter for device identification, or if it is going to be one of various systems. I do hope that we will only have to handle one system for this issue.
 
L

lfrost

#3
It is interesting that the proposed rule was released on July 2, 2012 and will be published in the Federal Registar sometime next week. Then will the comment period start. The biggest aspect of the rule is the "phased-in" process of the UDI system. After the Final rule is published, Class III manufacturers will have one year to become compliant with the rule. Three years after the final rule is published, Class II manufactures will need to become compliant. Class I manufactures will have five years after the final rule is published to become compliant. Interestingly, Class I manufacturers are the only ones that can obtain an exception to the rule if they already have UPC codes on their product and they are sold "over-the-counter" without prescription.

The actual proposed rule is the last 46 pages of the publication. The rest is the background that FDA went through to reach the proposed rule changes for UDI.

I have skimmed the proposed rule, and am also hopeful that the system which is finalized, becomes a standardized system which can be then adapted to all regulatory agencies so there is only one system of labels!:agree1:
 

lboll

Involved In Discussions
#5
The new FDA UDI proposal requires the expiration date to be formatted as MMM DD, YYYY with the month as 3 letters.
The MDD requires the expiration date as year and month, which we interpreted as YYYY/MM.
As a small company, we use 1 label for all devices regardless of where they are sold.
It appears as if we'll need to put the expiration date on our labels now in 2 different formats.
Is this how others are approaching the issue?
 
L

lfrost

#7
The new FDA UDI proposal requires the expiration date to be formatted as MMM DD, YYYY with the month as 3 letters.
The MDD requires the expiration date as year and month, which we interpreted as YYYY/MM.
As a small company, we use 1 label for all devices regardless of where they are sold.
It appears as if we'll need to put the expiration date on our labels now in 2 different formats.
Is this how others are approaching the issue?
You must remember that this is a proposed rule and not a finalized one. There is a 120-day comment period (which began July 10, 2012 when the proposed rule was published in the Federal Registar. This period is the time for you to comment with the rules that conflict with your current procedures. If you don't want two labels, then tell the FDA that two labels would be hard for you to do as well as a financial burden. Maybe they will change the rule to harmonize with the MDD dating as year and month.

I know it is wishful thinking, but now is the time that we have to see if we can change the FDA's thinking that some of the portions of the rule would bring about financial burdens on those small manufacturers of medical devices. My company is one that will have three years after the final rule is published before we have to comply because we manufacture class II devices.
 
W

Wanni

#8
I have a generall question in regards to the UDI Code. We already use GS1-128 and EAN-13 Code for our Medical Devices. Since we use this kind of codes already, what is the next step to fulfil the UDI requirements?

Looking forward for some help :bigwave:

Thank you in advance
 
L

lfrost

#9
right now the use of UDI is not necessary as it is only a proposed rule currently. Once it is finalized, you will have a graduated time between one to seven years until compliance will be required.
 
W

Wanni

#10
Thank you Ifrost, for your feedback.

Nevertheless I was wondering, if there will be an effect to our Barcode system (GS1-128 and EAN-13) which we already use and if yes, how?
 
Thread starter Similar threads Forum Replies Date
K UDI (Unique Device Identification) requirements of US FDA US Food and Drug Administration (FDA) 4
Ajit Basrur ICCBBA Is Now an FDA-Accredited Issuing Agency for Unique Device Identifiers (UDI) Other US Medical Device Regulations 1
Sam Lazzara 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2015) Other US Medical Device Regulations 45
Q FDA's Unique Device Identification, New Regulations - Pending March of 2010 ISO 13485:2016 - Medical Device Quality Management Systems 3
M FDA Unique Device Identifiers on the labeling of devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
X FDA UDI (Unique Identification) amendment on 19 Nov 2012 - Date of 'final rule'? US Food and Drug Administration (FDA) 4
T FDA level of concern vs IEC 62304 safety classification - 510(k) exempt device Other US Medical Device Regulations 6
K Change in address on ERLM US FDA: Implications to import US Medical Device Regulations 0
V FDA 510K - Pre Submission Query US Food and Drug Administration (FDA) 6
M Document Control ISO and FDA ISO 13485:2016 - Medical Device Quality Management Systems 7
C FDA 510k documentation requirements US Food and Drug Administration (FDA) 1
T Link GMDN code and FDA product code US Medical Device Regulations 5
cgaro62 Does FDA apply to a non-medical 13485 certified custom manufacturing company? ISO 13485:2016 - Medical Device Quality Management Systems 11
M How does FDA determine OAI and VAI after inspection? ISO 13485:2016 - Medical Device Quality Management Systems 0
K Non-Device MDDS Clarifications (FDA) US Food and Drug Administration (FDA) 7
Ed Panek Consultant Request SaMD AI "Expert" FDA US Food and Drug Administration (FDA) 2
Sam Lazzara Record signature requirements in proposed FDA 21 CFR 820 QMS Regulation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
shimonv FDA-recognized Standards US Food and Drug Administration (FDA) 0
R FDA ECG Data Requirements Medical Information Technology, Medical Software and Health Informatics 3
L Language of quality system in case of FDA inspection US Food and Drug Administration (FDA) 1
M Can you import medical device not FDA approved into the USA under an IND application? US Food and Drug Administration (FDA) 2
Ed Panek FDA Submits to White House Plan to Harmonize with ISO 13485 US Medical Device Regulations 2
Melissa Contract Mfg--to Manufacturer with the FDA ISO 13485:2016 - Medical Device Quality Management Systems 4
Ed Panek ANNUAL FDA Registration - What 510(k) number to use? US Food and Drug Administration (FDA) 1
Y FDA vs (EU) 2021/2226 Electronic Instructions for Use (eIFUs) US Medical Device Regulations 1
M FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS) US Food and Drug Administration (FDA) 0
JesseE Electronic signatures FDA CFR 820 ISO 13485:2016 - Medical Device Quality Management Systems 3
C FDA logo for marketing US Food and Drug Administration (FDA) 3
G FDA clearance for a device that can't be used clinically (at present) Other US Medical Device Regulations 5
M FDA Syringe Marking requirements US Food and Drug Administration (FDA) 4
K Guidance on X-Ray Medical Devices for Animal Use - FDA US Food and Drug Administration (FDA) 0
S FDA 510(K) submission question US Food and Drug Administration (FDA) 4
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 2
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
I If i do not want to be an initial importer should i register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B When FDA Decision Summary opens? US Food and Drug Administration (FDA) 4
Ed Panek FDA Remote Regulatory Assessment (RRA) Overview 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
B What is the difference btw RUO vs IUO for IVD in FDA guidance ? US Food and Drug Administration (FDA) 12
B How to submit Pre-submission to FDA? US Food and Drug Administration (FDA) 4
L FDA & 21 CFR Part 11 Medical Device and FDA Regulations and Standards News 19
B A.I. diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 6
Ed Panek 2020 FDA Top Ten Observations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M FDA Requirements for Investigational Devices - Clinical Investigation & Shipping Medical Device and FDA Regulations and Standards News 0
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B FDA Breakthrough Device can be overlapped with a designated device? US Food and Drug Administration (FDA) 6
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 5
S Examples of FDA acceptable Software Design Specification (SDS) Medical Device and FDA Regulations and Standards News 6
F Labelling to comply with both FDA and MDR US Food and Drug Administration (FDA) 6
Watchcat FDA vs NB Fees? Other US Medical Device Regulations 7
K FDA Registration and listing weird situation Medical Device and FDA Regulations and Standards News 4

Similar threads

Top Bottom