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Does FDA Need to Approve My Mobile Medical App?

Does the FDA Need to Approve My Mobile Medical App? Is it general educational material not intended to be patient-specific (e.g., EPDR, EMPR, preloaded imagery libraries, disease state or drug slide programs)? Does it display, store or transmit patient-specific data in its original format from a medical device (used as secondary displays not as primary diagnostic or treatment tools)? Is it used solely for monitoring, evaluating, decision-making or production of suggestions regarding developing or maintaining general health Does it control the intended use, function, modes, or energy source of the connected medical device and wellness that are not intended for CONSUMERS ARE THE AUDIENCE: MAY NEED APPROVAL. diagnostic or curative purposes? (essentially an operator)? Can it be used as a generic aid for medical tasks but is not marketed for a specific medical application (e.g., audio and video recording, task archiving, alarm systems)? Does it create alarms, recommendations, or create new information (data) through analysis or automate general office operations/functions such as billing/ coding, appointment-setting/tracking, automatic patient history-taking, and insurance transactions? Does interpretation of medical device data? Does it perform as an electronic health record system or personal health record system? Does it transform or make the mobile platform into a regulated medical device (such as enabling a smartphone to act as a heart monitor)? HCPS ARE THE AUDIENCE: NO APPROVAL NEEDED. cmi Communications Media Inc NO FDA APPROVAL NEEDED FDA APPROVAL NEEDED Does the FDA Need to Approve My Mobile Medical App? Is it general educational material not intended to be patient-specific (e.g., EPDR, EMPR, preloaded imagery libraries, disease state or drug slide programs)? Does it display, store or transmit patient-specific data in its original format from a medical device (used as secondary displays not as primary diagnostic or treatment tools)? Is it used solely for monitoring, evaluating, decision-making or production of suggestions regarding developing or maintaining general health Does it control the intended use, function, modes, or energy source of the connected medical device and wellness that are not intended for CONSUMERS ARE THE AUDIENCE: MAY NEED APPROVAL. diagnostic or curative purposes? (essentially an operator)? Can it be used as a generic aid for medical tasks but is not marketed for a specific medical application (e.g., audio and video recording, task archiving, alarm systems)? Does it create alarms, recommendations, or create new information (data) through analysis or automate general office operations/functions such as billing/ coding, appointment-setting/tracking, automatic patient history-taking, and insurance transactions? Does interpretation of medical device data? Does it perform as an electronic health record system or personal health record system? Does it transform or make the mobile platform into a regulated medical device (such as enabling a smartphone to act as a heart monitor)? HCPS ARE THE AUDIENCE: NO APPROVAL NEEDED. cmi Communications Media Inc NO FDA APPROVAL NEEDED FDA APPROVAL NEEDED Does the FDA Need to Approve My Mobile Medical App? Is it general educational material not intended to be patient-specific (e.g., EPDR, EMPR, preloaded imagery libraries, disease state or drug slide programs)? Does it display, store or transmit patient-specific data in its original format from a medical device (used as secondary displays not as primary diagnostic or treatment tools)? Is it used solely for monitoring, evaluating, decision-making or production of suggestions regarding developing or maintaining general health Does it control the intended use, function, modes, or energy source of the connected medical device and wellness that are not intended for CONSUMERS ARE THE AUDIENCE: MAY NEED APPROVAL. diagnostic or curative purposes? (essentially an operator)? Can it be used as a generic aid for medical tasks but is not marketed for a specific medical application (e.g., audio and video recording, task archiving, alarm systems)? Does it create alarms, recommendations, or create new information (data) through analysis or automate general office operations/functions such as billing/ coding, appointment-setting/tracking, automatic patient history-taking, and insurance transactions? Does interpretation of medical device data? Does it perform as an electronic health record system or personal health record system? Does it transform or make the mobile platform into a regulated medical device (such as enabling a smartphone to act as a heart monitor)? HCPS ARE THE AUDIENCE: NO APPROVAL NEEDED. cmi Communications Media Inc NO FDA APPROVAL NEEDED FDA APPROVAL NEEDED Does the FDA Need to Approve My Mobile Medical App? Is it general educational material not intended to be patient-specific (e.g., EPDR, EMPR, preloaded imagery libraries, disease state or drug slide programs)? Does it display, store or transmit patient-specific data in its original format from a medical device (used as secondary displays not as primary diagnostic or treatment tools)? Is it used solely for monitoring, evaluating, decision-making or production of suggestions regarding developing or maintaining general health Does it control the intended use, function, modes, or energy source of the connected medical device and wellness that are not intended for CONSUMERS ARE THE AUDIENCE: MAY NEED APPROVAL. diagnostic or curative purposes? (essentially an operator)? Can it be used as a generic aid for medical tasks but is not marketed for a specific medical application (e.g., audio and video recording, task archiving, alarm systems)? Does it create alarms, recommendations, or create new information (data) through analysis or automate general office operations/functions such as billing/ coding, appointment-setting/tracking, automatic patient history-taking, and insurance transactions? Does interpretation of medical device data? Does it perform as an electronic health record system or personal health record system? Does it transform or make the mobile platform into a regulated medical device (such as enabling a smartphone to act as a heart monitor)? HCPS ARE THE AUDIENCE: NO APPROVAL NEEDED. cmi Communications Media Inc NO FDA APPROVAL NEEDED FDA APPROVAL NEEDED Does the FDA Need to Approve My Mobile Medical App? Is it general educational material not intended to be patient-specific (e.g., EPDR, EMPR, preloaded imagery libraries, disease state or drug slide programs)? Does it display, store or transmit patient-specific data in its original format from a medical device (used as secondary displays not as primary diagnostic or treatment tools)? Is it used solely for monitoring, evaluating, decision-making or production of suggestions regarding developing or maintaining general health Does it control the intended use, function, modes, or energy source of the connected medical device and wellness that are not intended for CONSUMERS ARE THE AUDIENCE: MAY NEED APPROVAL. diagnostic or curative purposes? (essentially an operator)? Can it be used as a generic aid for medical tasks but is not marketed for a specific medical application (e.g., audio and video recording, task archiving, alarm systems)? Does it create alarms, recommendations, or create new information (data) through analysis or automate general office operations/functions such as billing/ coding, appointment-setting/tracking, automatic patient history-taking, and insurance transactions? Does interpretation of medical device data? Does it perform as an electronic health record system or personal health record system? Does it transform or make the mobile platform into a regulated medical device (such as enabling a smartphone to act as a heart monitor)? HCPS ARE THE AUDIENCE: NO APPROVAL NEEDED. cmi Communications Media Inc NO FDA APPROVAL NEEDED FDA APPROVAL NEEDED Does the FDA Need to Approve My Mobile Medical App? Is it general educational material not intended to be patient-specific (e.g., EPDR, EMPR, preloaded imagery libraries, disease state or drug slide programs)? Does it display, store or transmit patient-specific data in its original format from a medical device (used as secondary displays not as primary diagnostic or treatment tools)? Is it used solely for monitoring, evaluating, decision-making or production of suggestions regarding developing or maintaining general health Does it control the intended use, function, modes, or energy source of the connected medical device and wellness that are not intended for CONSUMERS ARE THE AUDIENCE: MAY NEED APPROVAL. diagnostic or curative purposes? (essentially an operator)? Can it be used as a generic aid for medical tasks but is not marketed for a specific medical application (e.g., audio and video recording, task archiving, alarm systems)? Does it create alarms, recommendations, or create new information (data) through analysis or automate general office operations/functions such as billing/ coding, appointment-setting/tracking, automatic patient history-taking, and insurance transactions? Does interpretation of medical device data? Does it perform as an electronic health record system or personal health record system? Does it transform or make the mobile platform into a regulated medical device (such as enabling a smartphone to act as a heart monitor)? HCPS ARE THE AUDIENCE: NO APPROVAL NEEDED. cmi Communications Media Inc NO FDA APPROVAL NEEDED FDA APPROVAL NEEDED Does the FDA Need to Approve My Mobile Medical App? Is it general educational material not intended to be patient-specific (e.g., EPDR, EMPR, preloaded imagery libraries, disease state or drug slide programs)? Does it display, store or transmit patient-specific data in its original format from a medical device (used as secondary displays not as primary diagnostic or treatment tools)? Is it used solely for monitoring, evaluating, decision-making or production of suggestions regarding developing or maintaining general health Does it control the intended use, function, modes, or energy source of the connected medical device and wellness that are not intended for CONSUMERS ARE THE AUDIENCE: MAY NEED APPROVAL. diagnostic or curative purposes? (essentially an operator)? Can it be used as a generic aid for medical tasks but is not marketed for a specific medical application (e.g., audio and video recording, task archiving, alarm systems)? Does it create alarms, recommendations, or create new information (data) through analysis or automate general office operations/functions such as billing/ coding, appointment-setting/tracking, automatic patient history-taking, and insurance transactions? Does interpretation of medical device data? Does it perform as an electronic health record system or personal health record system? Does it transform or make the mobile platform into a regulated medical device (such as enabling a smartphone to act as a heart monitor)? HCPS ARE THE AUDIENCE: NO APPROVAL NEEDED. cmi Communications Media Inc NO FDA APPROVAL NEEDED FDA APPROVAL NEEDED

Does FDA Need to Approve My Mobile Medical App?

shared by CommunicationsM... on Nov 17
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Content determines whether an app requires FDA approval. Essentially, and with some exceptions, an app only needs FDA approval if it handles private patient information, is used to make a diagnosis, a...

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