FDA guidelines for mobile health apps relevant to cognitive/ mental health

21 types of health apps the FDA could regulate but won’t (MobiHealthNews): “The FDA final guidance finally published last week and it included very few surprises. One new section in the final guidelines — that was not included in the draft guidance — is a list of the types of apps that the FDA says will fall under its enforcement discretion. That means that these apps may meet the definition of a medical device, but the “FDA intends to exercise enforcement discretion for these mobile apps because they pose lower risk to the public…In the pages to follow is a roundup of the FDA’s list of apps that it does not intend to regulate even though they meed the definition of a medical device.” #1 Some Psychiatric Apps “According to the FDA’s guidance, some psychiatric apps might meet the definition of a mobile device, but it will choose not to regulate some of these apps: “Mobile apps that help patients with diagnosed psychiatric conditions (e.g., post-traumatic stress disorder (PTSD), depression, anxiety, obsessive compulsive disorder) maintain their behavioral coping skills by providing a ‘Skill of the Day’ behavioral technique or audio messages that the user can access when experiencing increased anxiety” #8 Preventative screening apps from established medical sources “Mobile apps that use patient characteristics such as age, sex, and behavioral risk factors to provide patient-specific screening, counseling and preventive recommendations from well-know...
Source: SharpBrains - Category: Neurologists Authors: Tags: Education & Lifelong Learning Health & Wellness Technology anxiety depression FDA medical device mobile apps psychiatric apps Source Type: blogs