FDA is issuing this guidance to communicate how the Agency intends to apply its regulatory oversight to certain software, including device software functions and mobile medical applications (MMAs) intended for use on mobile platforms or on general-purpose computing platforms. FDA intends to apply its regulatory oversight to those device software functions that meet the definition of a medical device and whose functionality could pose a risk to a patient’s safety if the device were not to function as intended. This guidance describes FDA’s policy for device software functions and MMAs that meet the device definition, including some that are the focus of FDA’s regulatory oversight and some for which FDA does not intend to enforce requirements under the Federal Food, Drug, and Cosmetic Act. This guidance also provides information on some software functions that do not meet the device definition, and as such, are software functions that are not subject to applicable FDA regulatory requirements.
FDA is issuing this guidance to provide clarity and predictability for software manufacturers on this topic.
This guidance was revised through a minor update to reflect amended medical device classification regulations following the issuance of the final rule, “Medical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act” (86 FR 20278), as well as to update content impacted by issuance of the final guidance, “Clinical Decision Support Software.”