09-27-2019 - CDRH New

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on September 26, 2019. To view listings for other dates, see CDRH New - News and Updates.

Digital Health Device Software Functions Including Mobile Medical Applications Press Release: Statement on new steps to advance digital health policies that encourage innovation and enable efficient and modern regulatory oversight Clinical Decision Support Software - Draft Guidance for Industry and Food and Drug Administration Staff Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act - Guidance for Industry and Food and Drug Administration Staff Policy for Device Software Functions and Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff General Wellness: Policy for Low Risk Devices - Guidance for Industry and Food and Drug Administration Staff Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff Automated External Defibrillators (AEDs)