FDA Class 1 Medical Device UDI requirements

J

jkc3usc

Involved In Discussions
#1
#1
I have not found much information on Class 1 minimum requirements. I know the UDI contains the DI and PI but to what extent. Also we make product that could have a blue color, or a red, or a green, does that mean I need a separate UDI for all different colors and options? Just seems overkill if it still all under the same product family. Does anyone have an example or could send me in the right direction?
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
J

jkc3usc

Involved In Discussions
#3
#3
Ronen E said:
21 CFR 801.20
21 CFR 830
Unique Device Identification - UDI
Click to expand...
Correct and I have looked there. When you go to gs1 they compare how many barcodes I will need to t shirt with sizes and colors. I find it hard to believe I will need 10s of thousands of barcodes for the 15 products we have then. I don't see how I will need a bar code for a product that we offer in 20 colors? that's already now 300 barcodes, then also add in bar codes for the different options of a headrest lets say 7 that's just the begining. Just doesn't make sense.

I can see a barcode for a product if there is a size or voltage difference but not colors, or simple options.
 
S

SMBIZZQA

Starting to get Involved
#4
#4
Regarding Class 1, I have been advised that the PI is not required on a class 1 product, that a UPC will meet UDI requirements.
Also refer to 21 CFR 801.30 (11) (d).
It is voluntary if you wish to add it.
 
A

AUDITGIRL

Registered
#7
#7
if you are asking does a class I medical device need registration and Device Listing. the answer is yes. If you are asking about UDI labels, see the link above for the compliance dates for Class I and unclassified devices. It is my understanding that if you have a class I device and it does not require GMP then it will not require a UDI when the compliance date arrives (currently September 2020). Hope this helps.
~Deb
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
D FDA Approved Class II Medical Device? Other US Medical Device Regulations 11
L A Taiwan company want to sell Class I medical device (510(k) exempt) on Amazon, should we register with FDA? US Food and Drug Administration (FDA) 4
N Per the FDA regulations can a medical device be class I despite that it is sterile? Other Medical Device Related Standards 4
I The likelihood of approval by the FDA for a Class II Medical Device US Food and Drug Administration (FDA) 8
B Will FDA Inspect a New Coating Supplier for a Class III Combination Medical Device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
I FDA Exempts Product Codes from 510(k) Process (Class II Medical Devices) US Food and Drug Administration (FDA) 0
S FDA Class I Medical Device Safety and Efficacy Data Requirements Other US Medical Device Regulations 5
I FDA Class II Medical Device Clinical Trials and and FDA IDE Requirements US Food and Drug Administration (FDA) 3
B FDA Listing of a Class I Medical Device in USA (Manufactured in China) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
F EU Useability Study for FDA? Class II Medical Device IEC 62366 - Medical Device Usability Engineering 10
T FDA Requirements - Class 1 Exempt Medical Device Recall ISO 13485:2016 - Medical Device Quality Management Systems 2
P FDA requirements for Exempted Class I Medical Devices Other US Medical Device Regulations 5
A What to expect if FDA wants to inspect a Class 1 Medical Device Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 1
I FDA Cleanroom requirements for class II in vitro medical devices US Food and Drug Administration (FDA) 1
M ISO 13485 and Class 1 Medical Device - FDA thinking ISO 13485:2016 - Medical Device Quality Management Systems 14
Q Search for FDA Class I Medical Device Listings US Food and Drug Administration (FDA) 5
D FDA Reclassification of Medical Devices - Class III device down to Class II 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Registering a Class II Medical Device with no Predicate Device - FDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S FDA Consultant Needed for Class I Medical Device Development 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Minimum US FDA Labeling Requirements for a Class II Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
A Guidance on Cleaning & Sterilization of an FDA Class II Medical Device US Food and Drug Administration (FDA) 4
E How to get FDA Approval for Class II Medical Device - We have CE Mark, 13485, 9001 US Food and Drug Administration (FDA) 12
M FDA QSR Requirements - Checklist for Class II Medical Device Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R Handguns are now FDA Class I medical devices.... 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
S Only the FDA can sell in USA - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T FDA Class III Medical Device Modification - 510k Application 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
N Reference to FDA on Label or Labelling - Class II Medical Device US Food and Drug Administration (FDA) 7
L Medical Devices FDA 510k third part review? Class II Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 3
E FDA - Design Control Forms - Medical devices (Class I and II 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Edward Reesor FDA DM and /or Class I Life Saving US Food and Drug Administration (FDA) 0
M PMS template for FDA submission (De novo submission for a Class II IVD) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
M Informational FDA Classifies Suitable Accessories into Class I as Required by the FDA Reauthorization Act of 2017 Medical Device and FDA Regulations and Standards News 0
M Medical Device News FDA Guidance - UDI: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking Other US Medical Device Regulations 0
D FDA UDI Class I Compliance Date Extended US Food and Drug Administration (FDA) 1
J Manufacturing CRL - Class 1 or Class 2 Inspection (FDA form 483) US Food and Drug Administration (FDA) 1
Q US FDA UDI Compliance Question - Class II (Special Controls) Other Medical Device and Orthopedic Related Topics 4
somashekar Pre-Announced FDA 4 Day Inspection, Class 2 Devices, Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
ScottK FDA Listing a Class I that goes into a Class II 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
F FDA Device List For Class 1 510K Exempt Devices US Food and Drug Administration (FDA) 8
B Does a US FDA Class I (exempt) device require a Statement of Intended Use? Other US Medical Device Regulations 3
H Distribution of 'Free of charge' FDA Class I Devices ISO 13485:2016 - Medical Device Quality Management Systems 1
T IEC 62304 & FDA: Software Development Methodologies for Class II- DICOM device IEC 62304 - Medical Device Software Life Cycle Processes 8
P FDA Application for a Class IIa CE Marked Product bought from another company US Food and Drug Administration (FDA) 2
M CE requirement for software importer / reseller - Class II for FDA and Health Canada EU Medical Device Regulations 1
S Interesting Discussion FDA 510(k) required? US company Private Labeling an FDA Class II Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 34
L CE Mark - FDA - Class I traction systems - What is involved and how long does it take EU Medical Device Regulations 5
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
Watchcat FDA will not tolerate fraud…meaning what, exactly? Other US Medical Device Regulations 6
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 2
Similar threads
Top Bottom