The US Food and Drug Administration (FDA) has issued final guidance documents regarding the agency’s approach on the regulation of medical device data systems (MDDS) and mobile applications.
MDDS is described as hardware or software that transfers, stores, converts formats, and displays medical device data from a variety of other devices including glucose meters, blood pressure cuffs and weight scales.
The agency said that its guidance document was issued to inform manufacturers, distributors and other entities that the FDA 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.
The final guidance replaced the draft guidance issued in June, which contained virtually no changes.
In 2011, the agency issued a regulation changing the classification of MDDS from Class III (high-risk) to Class I (low-risk). Class I devices are subject to general controls under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Since down-classifying MDDS, the agency has gained additional experience with these technologies and determined they pose a low risk to the public.
The approach is expected to smooth the way for interoperability by lowering the burden for MDDS developers.
Additionally, in a separate final guidance, the FDA said that it plans to regulate mobile health applications based on functionality, rather than their scale. The agency said that it intends to apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended. The FDA refers to these subset of mobile applications as mobile medical apps. The agency defined mobile medical apps as apps to be used as an accessory to a regulated medical device; or to transform a mobile platform into a regulated medical device.
“We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health in a previous press release announcing the agency’s final guidance on mobile medical apps. “Our mobile medical app policy provides app developers with clarity needed to support the continued development of these important products.”
Sources: MDDS guidance