Question

A smart phone app that analyzes and interprets blood pressure readings to detect irregularities is a _________ according to FDA guidance.

Answer 1

A smart phone app that analyzes and interprets blood pressure readings to detect irregularities is considered a medical device according to FDA guidance.

Step-by-step explanation:

A smart phone app that analyzes and interprets blood pressure readings to detect irregularities is considered a medical device according to FDA guidance. Medical devices are defined as products that diagnose, treat, or prevent diseases or medical conditions. The FDA has established guidelines for the regulation of mobile medical applications, including apps that analyze and interpret health data like blood pressure readings.