BN Business News
Add your company to Business Communicator →

Zdrowie i gospodarka · 9.02.2015

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices; Mobile Medical Applications: Guidances for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA) is announcing the availability of two guidance documents. FDA is issuing "Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices" to inform manufacturers, distributors, and other entities that the Agency does not intend to enforce compliance with regulatory requirements for Medical Device Data Systems (MDDS) and two similar radiology device types due to the low risk they pose to patients and the importance they play in advancing digital health. FDA is also issuing an updated version of the guidance document "Mobile Medical Applications," originally issued on September 25, 2013, that has been edited to be consistent with the MDDS guidance document.

Source: Federal Register — Food and Drug AdministrationOpen original release →