SBS - The best value in QMS software

Medical device mobile app UDI - Where is the UDI labelled?

S

snoopy2017

#1
#1
Hi everyone,

For a digital health app, where is the UDI labelled? Is there a new PI for each software version/release? Thank you.
 
12 questions to ask before buying a QMS
Elsmar Forum Sponsor
DEVigil

DEVigil

Involved In Discussions
#2
#2
The app should follow the same requirements as standalone software, which is governed by 21 CFR 801.50:

(a) Stand-alone software that is not distributed in packaged form (e.g., when downloaded from a Web site) is deemed to meet the UDI labeling requirements of this subpart if it complies with the requirements of paragraph (b) of this section and conveys the version number in its production identifier.
(b) Regardless of whether it is or is not distributed in packaged form, stand-alone software regulated as a medical device must provide its unique device identifier through either or both of the following:
(1) An easily readable plain-text statement displayed whenever the software is started;
(2) An easily readable plain-text statement displayed through a menu command (e.g., an "About * * *" command).
Click to expand...
Presumably the app has a Menu or Settings option for users, in which you can place an About This App (similar to the Help About screen in other software).

As for the new PI for each version/release, the answer is yes. The point of the UDI is to be able to identify the exact product in question. How would else you know which versions were potentially affected by a bug reported by a user? Not all users update their apps every time one is available, so you can't rely on it just being whichever you're offering at the moment.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Are DAM tools, Mobile application, clinical dashboard, etc. considered accessories to medical device or supportive functions? Manufacturing and Related Processes 4
E Wearable Medical Device & Mobile Apps in US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
E Wearable Medical Device & Mobile Apps in EU EU Medical Device Regulations 1
S Do you test the download and installation of a mobile medical device app? Software Quality Assurance 6
C Mobile Application which collects Physiological Data from a Medical Device Other Medical Device and Orthopedic Related Topics 1
E Medical Device supplemented with a Mobile Application IEC 62366 - Medical Device Usability Engineering 4
J Mobile Medical Device App Validation Guidance vs. GPSV? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D Regulation Approach on Mobile Application which is Medical Device Acccesory EU Medical Device Regulations 1
C Mobile Medical Device for MDD - Medical Image Viewer EU Medical Device Regulations 2
M (medical device) V&V phase: justification of acceptance criteria (statistical method ?) Design and Development of Products and Processes 0
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 1
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 1
M Medical device substance based-leachables Other Medical Device Related Standards 1
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
L Medical Device Registration in Macau Other US Medical Device Regulations 1
A Medical Device Registration in the Dominican Republic Other Medical Device Regulations World-Wide 4
Aymaneh Medical Device Cybersecurity Risk Management IEC 27001 - Information Security Management Systems (ISMS) 2
T B2C Medical Device Shipping across the US Other Medical Device Related Standards 0
M Medical Device Registration In Malaysia Other Medical Device Regulations World-Wide 2
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
V Sister companies selling same medical device under different names ISO 13485:2016 - Medical Device Quality Management Systems 3
K CE Marking for Class I Medical Device? CE Marking (Conformité Européene) / CB Scheme 7
L Medical device storage conditions ISO 13485:2016 - Medical Device Quality Management Systems 1
F USB powered handheld medical device - Isolation requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
L How to determine / validate Medical Device Storage Conditions ISO 13485:2016 - Medical Device Quality Management Systems 1
P Best european location to set up for a virtual medical device manufacturer? EU Medical Device Regulations 4
Y Possibility for Medical Device registration in Israel Regulation Other Medical Device Regulations World-Wide 4
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Determining if an Insulin Pen Testing Machine is a Medical Device? EU Medical Device Regulations 4
M Indian Medical Device Rules - Manufacturing and Wholesale Lic. Required ? Other Medical Device Regulations World-Wide 3
K Medical Device Repairs and ISO Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
R Manufacturing plants relocation - Medical Device Medical Device and FDA Regulations and Standards News 7
R Medical Device - Change manufacturing plant Design and Development of Products and Processes 6
shimonv Classification of a cloud- base viewer for the output from a medical device US Food and Drug Administration (FDA) 7
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 6
A Medical device Mode Of Action CE Marking (Conformité Européene) / CB Scheme 2
P Best Global Option to become an OBL/PLM/Virtual medical device brand in 2020 Other Medical Device Regulations World-Wide 2
rob73 UK Medical Device Regulations Forum - UK MDR Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
S Philippines CMDL (Certificate of Medical Device Listing) Elsmar Cove Forum ToS and Forum Policies 0
J 21 CFR 821 Medical Device Tracking Requirement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Iraq Medical Device registration Other Medical Device Regulations World-Wide 0
R Medical Device Software Certification IEC 62304 - Medical Device Software Life Cycle Processes 1
D Class IIB Medical Device Accessories - OTS Tablets Other Medical Device Regulations World-Wide 1
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
T Clinical evaluation of a new medical device EU Medical Device Regulations 0
7 Iraq Medical Device Chemical Regulations Other Medical Device Regulations World-Wide 0

Similar threads

Top Bottom