New Draft Guidance Would Clear Regulatory Hurdles for Software Developers

On June 20, 2014, the Food and Drug Administration issued a draft guidance titled ‘‘Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices’’ (‘‘MDDS draft guidance’’) (8 MELR 423, 6/25/14). The draft announces that FDA does not intend to enforce compliance with the regulatory controls that apply to Medical Device Data Systems (MDDS), medical image storage devices, or medical image communications devices, because of the low risk they pose to patients and the importance they play in advancing digital health.

Reproduced with permission from Medical Devices Law & Industry Report, 8 MELR 512, 07/23/2014. Copyright 2014 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com