FDA classification for a mobile app

#1
We currently have a class II medical device. The device collects date which is then uploaded to a cloud server using a PC whare its is accessed by clinicians.
Question is if we were to create and app and upload the same dats to the server via a cell connection what type of regulatory would be required?
 
Elsmar Forum Sponsor
#2
Thank you for your reply. The device is a simple data recorder. There would be no safety issue that using an app would create. All the app does is pull the data from the recorder after it has been collected and and pushes it to a cloud server. Really just replaces the PC application that does the same.

Sounds like a class II 510k is the answer.
 
#3
Frank - most devices as such are classified as a Class IIa - however, the specifics of the device will determine this. With you mentioning that the risk is low - my initial thought is IIa
 

monoj mon

Quite Involved in Discussions
#4
Frank - most devices as such are classified as a Class IIa - however, the specifics of the device will determine this. With you mentioning that the risk is low - my initial thought is IIa
The original question was about FDA classification, not EU classification. There is no such a/b classification in FDA.
 
Thread starter Similar threads Forum Replies Date
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
dinaroxentool Question about FDA Classification of a Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Informational US FDA – Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Acceptance Review for De Novo Classification Requests Medical Device and FDA Regulations and Standards News 1
M FDA News The FDA Issues Final Rule on Medical Device Classification Procedures Medical Device and FDA Regulations and Standards News 0
J FDA classification and registration for a software plugin 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B FDA Product Classification - Self Treatment Software Applications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
H FDA Classification of a Body Weight 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S FDA and OTC (Over the Counter) Software Use Classification Medical Information Technology, Medical Software and Health Informatics 9
A FDA "Product Code" Classification Basics US Food and Drug Administration (FDA) 8
S Proper FDA Classification for a DICOM Viewer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 29
R FDA Rules on Medical Device Classification Listings? Other US Medical Device Regulations 3
Y FDA Classification for Medical Device Power Adaptors (Power Supplies) Other US Medical Device Regulations 12
M Level of Concern (FDA) vs. Software Safety Classification(IEC) US Food and Drug Administration (FDA) 3
S New draft FDA Classification Guidance US Food and Drug Administration (FDA) 1
R Medical Device FDA - Classification of a device used as an interface with a computer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
L Medical Device FDA Product Classification help needed 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T FDA Single Use Instruments - Classification Help Needed 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
thisby_ FDA, Classification Rules & Medical Software Devices US Food and Drug Administration (FDA) 3
sagai In Vitro Scanner Device (IVD) FDA Classification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C Classification of a Medical Device in FDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
D FDA Information - Revising the Instructions for Use US Food and Drug Administration (FDA) 0
S Transitional Adolescent A and B - "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514" Medical Device and FDA Regulations and Standards News 1
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
P MSDS for MVQ FDA White, Vinyl Methyl Silicone Rubber EU Medical Device Regulations 4
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5
E FDA 513(g) Cover Letter US Food and Drug Administration (FDA) 5
S Records - Do's and don't' of record entries (FDA - 21 CFR 820) Records and Data - Quality, Legal and Other Evidence 13
B New Facility register with FDA Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J FDA regulation on decorative contact lenses Medical Device and FDA Regulations and Standards News 5
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
P Writing a presubmission to the FDA prior to the De novo submission US Food and Drug Administration (FDA) 4
K FDA - Can we have more than 1 Initial Importer Medical Device and FDA Regulations and Standards News 4
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
R Importers - For the FDA Registration/ Listing, is the CMO the importer? Medical Device and FDA Regulations and Standards News 6
Z Iterative development and FDA change requests IEC 62304 - Medical Device Software Life Cycle Processes 13
P FDA Approved Product Contact Parts ISO 13485:2016 - Medical Device Quality Management Systems 6
O Clarifying FDA definition of "finished device" and “capable of functioning” 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2

Similar threads

Top Bottom