The Food and Drug Administration has released draft guidance for the health industry on the agency’s stance regarding regulatory compliance related to medical device data systems, medical image storage and communications devices.
According to the guidance posted Friday on the FDA website, the agency’s Center for Devices and Radiological Health will not mandate compliance to controls related to MDDS and the medical image devices, including registration, premarket review and postmarket reporting.
The FDA said this decision is due to the devices’ re-classification from high-risk to low-risk and their potential contribution to the continued development of digital health technology.
The agency also indicated a few proposed changes to the 2013 Mobile Medical Applications guidance to conform to FDA’s policy on the mentioned devices.
Comments and suggestions from MDDS and medical image device manufacturers and distributors will be accepted through Aug. 19 via the Regulations.gov website or mail sent to FDA’s Division of Dockets Management.