In a new final guidance issued on Friday, the U.S. Food and Drug Administration (FDA) confirmed it would no longer regulate technologies that receive, store, or display data from medical devices, including those used to store and communicate medical images.
After originally down-classifying medical device data systems (MDDS) from class III (high risk) to class I (low risk) devices in February 2011, the FDA said it has gained more experience with the technologies and determined that the devices pose a low risk to the public. They also play an important role in advancing digital health, according to the FDA.
"Therefore, the FDA does not intend to enforce compliance with the regulatory controls that apply to MDDS devices, medical image storage devices, and medical image communications devices," the agency said.
As defined by the FDA, medical image storage devices provide electronic storage and retrieval functions for medical images, while a medical communications device provides electronic transfer of medical image data between devices. The new guidance can be found here. PACS, however, remains a class II device under FDA oversight.
To ensure consistency, the FDA has also updated its Mobile Medical Applications guidance and added new examples into its appendices. For instance, mobile apps that are not intended for diagnostic image review would be considered medical image communications devices and classified among the mobile apps for which the FDA intends to exercise enforcement discretion -- meaning it does not intend to regulate them.
This policy would cover apps such as those that provide "image display for multidisciplinary patient management meetings (e.g., rounds) or patient consultation (and include a persistent on-screen notice, such as 'for informational purposes only and not intended for diagnostic use')," according to the guidance.
The updated mobile medical apps guidance can be found here.
