The Food and Drug Administration (FDA) recognizes that the progression to digital health offers the potential for better, more efficient patient care and improved health outcomes. To achieve this goal requires that many medical devices be interoperable with other types of medical devices and with various types of health information technology. The foundation for such inter-communication is hardware and software, typically referred to as medical device data systems (MDDS) that transfer, store, convert formats, and display medical device data or medical imaging data.

On February 15, 2011, the FDA issued a regulation down-classifying MDDS from Class III (high-risk) to Class I (low-risk) ("MDDS regulation").¹ Since down-classifying MDDS, the FDA has gained additional experience with these types of technologies, and has determined that these devices pose a low risk to the public. On February 9, 2015, the FDA issued a guidance document to inform manufacturers, distributors, and other entities that the Agency does not intend to enforce compliance with the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices, due to the low risk they pose to patients and the importance they play in advancing digital health.

Since the issuance of the guidance document in 2015, section 3060(a) of the 21st Century Cures Act (Cures Act) amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) on December 13, 2016, removing certain software functions from the definition of device in section 201(h) of the FD&C Act. Pursuant to section 520(o)(1)(D) of the FD&C Act, software functions that are solely intended to transfer, store, convert formats, and display medical device data or medical imaging data, unless the software function is intended to interpret or analyze clinical laboratory test or other device data, results, and findings, are not devices and are not subject to FDA laws and regulations applicable to devices. The definition of MDDS in 21 CFR 880.6310 is currently inconsistent with the definition of device as amended pursuant to the Cures Act. FDA intends to amend the regulation to be consistent with the amended device definiton. FDA's current thinking on the definition of MDDS is reflected in this guidance.

Hardware products that are intended to transfer, store, convert formats, and display medical device data and results remain devices under section 201(h) of the FD&C Act. FDA does not intend to enforce compliance with the regulatory controls for such devices, provided that the hardware function is limited to assisting the following software functions: electronic transfer, storage, conversion of formats, or display of medical device data.

The policy described in this guidance document is also consistent with the Agency's updated guidance entitled "Policy for Device Software Functions and Mobile Medical Applications," originally issued on February 9, 2015, with the title "Mobile Medical Applications."

¹ See Medical Devices; Medical Device Data Systems Final Rule (76 FR 8637) (Feb. 15, 2011).