FDA classification for a mobile app

Frank Katarow

Starting to get Involved
#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

Frank Katarow

Starting to get Involved
#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

Trusted Information Resource
#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
T FDA level of concern vs IEC 62304 safety classification - 510(k) exempt device Other US Medical Device Regulations 13
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 5
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) 5
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
Y Convenience pack FDA US Food and Drug Administration (FDA) 1
B FDA regulations medical device prescription fulfillment DME question US Medical Device Regulations 0
N FDA medical devices US Food and Drug Administration (FDA) 1
R US FDA 510k Australia TGA US Food and Drug Administration (FDA) 0
B How FDA define a new variant/generation or a new device US Medical Device Regulations 11
G FDA Annual Registration and Listing US Food and Drug Administration (FDA) 7
T Book Excerpt: Drugs and the FDA: Safety, Efficacy, and the Public’s Trust Book, Video, Blog and Web Site Reviews and Recommendations 0
E The FDA regulations (21 CFR 312.3): Is it allowable that IND sponsor involves more than one individual or organization? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
P Looking for Korean FDA Drug Master File requirements for packaging systems. Other Medical Device and Orthopedic Related Topics 1
M IEC 62366 Hazard-related Use Scenario vs FDA Critical Task EU Medical Device Regulations 3
N Free sale and FDA US Food and Drug Administration (FDA) 1
N FDA class 1 US Food and Drug Administration (FDA) 6
G UDI in EU vs FDA EU Medical Device Regulations 1
S Initial Audit FDA US Medical Device Regulations 3
T FDA PMA review process - advisory panel timing? Other Medical Device and Orthopedic Related Topics 0
E FDA & Internal Audits US Medical Device Regulations 3
N Importing into US without 510K/FDA Clearance US Medical Device Regulations 1
N FDA class 2 Device QS Requirements US Food and Drug Administration (FDA) 2
T FDA labeling requirements US Food and Drug Administration (FDA) 2
S FDA Contract Manufacturer and Applicant US Food and Drug Administration (FDA) 0
R IVD Software FDA/CLIA doubts Medical Device and FDA Regulations and Standards News 1
R IVD software FDA and CLIA US Food and Drug Administration (FDA) 2
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

Similar threads

Top Bottom