Regulatory Open Forum

What does FDA enforcement discretion (does not intend to enforce requirements under the FD&C Act) really mean with respect to mobile medical apps (Policy for Device Software Functions and Mobile Medical Applications (fda.gov))?<o:p></o:p>

Could this be interpreted as there may be leeway to reduce regulatory requirements to a non-medical device or as a 'health software' or does it mean that the app becomes either a Class 1 exempt or Class 2 exempt device, and the device is not subject to formal review by the FDA, in other words no 510(k), but you are still required to have a QMS, design controls, FDA Registration but it's still regulated by the FDA as a medical device?<o:p></o:p>

This policy of FDA is to provide guidance on mobile apps , medical and non medical . There are mobile health care apps which may require  FDA oversight, Software functions that become a regulated medical device by performing patient-specific analysis and providing specific output(s) or directive(s) to healthcare professionals for use in the diagnosis, treatment, mitigation, cure, or prevention of a disease or condition. There may be apps that help patient manage a disease condition or even help healthcare professional automate some tasks, again FDA intends to exercise enforcement discretion these. It means by case-by-case basis these are delt with. Yes, there are mobile apps that can be class1 or 510k exempt, general controls do apply to these. Manufacturers can use this to streamline their app intended use and functions, if they really want to make it a medical app or healthcare or non-medical app. can we call it leeway or room for manufacturers to decide if they want to step on and become a medical device or stay off. At least by registering and listing these exempt mobile apps are under FDA radar, the updates are again having to be reviewed to see if FDA needs to be involved. it is some kind of control.

What does FDA enforcement discretion (does not intend to enforce requirements under the FD&C Act) really mean with respect to mobile medical apps (Policy for Device Software Functions and Mobile Medical Applications (fda.gov))?<o:p></o:p>

Could this be interpreted as there may be leeway to reduce regulatory requirements to a non-medical device or as a 'health software' or does it mean that the app becomes either a Class 1 exempt or Class 2 exempt device, and the device is not subject to formal review by the FDA, in other words no 510(k), but you are still required to have a QMS, design controls, FDA Registration but it's still regulated by the FDA as a medical device?<o:p></o:p>

Thanks Raje for your response. <o:p></o:p>

In relation to the example you have given below,  "apps that help patient manage a disease condition or even help healthcare professional automate some tasks", can you elaborate on what you mean by "FDA intends to exercise enforcement discretion these".<o:p></o:p>

This policy of FDA is to provide guidance on mobile apps , medical and non medical . There are mobile health care apps which may require  FDA oversight, Software functions that become a regulated medical device by performing patient-specific analysis and providing specific output(s) or directive(s) to healthcare professionals for use in the diagnosis, treatment, mitigation, cure, or prevention of a disease or condition. There may be apps that help patient manage a disease condition or even help healthcare professional automate some tasks, again FDA intends to exercise enforcement discretion these. It means by case-by-case basis these are delt with. Yes, there are mobile apps that can be class1 or 510k exempt, general controls do apply to these. Manufacturers can use this to streamline their app intended use and functions, if they really want to make it a medical app or healthcare or non-medical app. can we call it leeway or room for manufacturers to decide if they want to step on and become a medical device or stay off. At least by registering and listing these exempt mobile apps are under FDA radar, the updates are again having to be reviewed to see if FDA needs to be involved. it is some kind of control.

What does FDA enforcement discretion (does not intend to enforce requirements under the FD&C Act) really mean with respect to mobile medical apps (Policy for Device Software Functions and Mobile Medical Applications (fda.gov))?<o:p></o:p>

Could this be interpreted as there may be leeway to reduce regulatory requirements to a non-medical device or as a 'health software' or does it mean that the app becomes either a Class 1 exempt or Class 2 exempt device, and the device is not subject to formal review by the FDA, in other words no 510(k), but you are still required to have a QMS, design controls, FDA Registration but it's still regulated by the FDA as a medical device?<o:p></o:p>

Typically case by case FDA may or may not enforce. It will depend on kind of medical app how much does it help make decision/diagnosis ect. 

Thanks Raje for your response. <o:p></o:p>

In relation to the example you have given below,  "apps that help patient manage a disease condition or even help healthcare professional automate some tasks", can you elaborate on what you mean by "FDA intends to exercise enforcement discretion these".<o:p></o:p>

This policy of FDA is to provide guidance on mobile apps , medical and non medical . There are mobile health care apps which may require  FDA oversight, Software functions that become a regulated medical device by performing patient-specific analysis and providing specific output(s) or directive(s) to healthcare professionals for use in the diagnosis, treatment, mitigation, cure, or prevention of a disease or condition. There may be apps that help patient manage a disease condition or even help healthcare professional automate some tasks, again FDA intends to exercise enforcement discretion these. It means by case-by-case basis these are delt with. Yes, there are mobile apps that can be class1 or 510k exempt, general controls do apply to these. Manufacturers can use this to streamline their app intended use and functions, if they really want to make it a medical app or healthcare or non-medical app. can we call it leeway or room for manufacturers to decide if they want to step on and become a medical device or stay off. At least by registering and listing these exempt mobile apps are under FDA radar, the updates are again having to be reviewed to see if FDA needs to be involved. it is some kind of control.

What does FDA enforcement discretion (does not intend to enforce requirements under the FD&C Act) really mean with respect to mobile medical apps (Policy for Device Software Functions and Mobile Medical Applications (fda.gov))?<o:p></o:p>

Could this be interpreted as there may be leeway to reduce regulatory requirements to a non-medical device or as a 'health software' or does it mean that the app becomes either a Class 1 exempt or Class 2 exempt device, and the device is not subject to formal review by the FDA, in other words no 510(k), but you are still required to have a QMS, design controls, FDA Registration but it's still regulated by the FDA as a medical device?<o:p></o:p>