List of FDA Guidance Documents with DH content
- (NEW) Software as a Medical Device (SAMD): Clinical Evaluation – Guidance for Industry and Food and Drug Administration Staff (PDF – 1.2MB) -December 08, 2017
- (NEW) Clinical and Patient Decision Support Software – Draft Guidance for Industry and Food and Drug Administration Staff (PDF – 461KB) -December 08, 2017
- (NEW) Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act – Draft Guidance for Industry and Food and Drug Administration Staff (PDF – 547KB) -December 08, 2017
- Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices – Guidance for Industry and Food and Drug Administration Staff (PDF – 650KB) -February 09, 2015
- General Wellness: Policy for Low Risk Devices – Guidance for Industry and Food and Drug Administration Staff (PDF – 786KB) -July 29, 2016
- Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices – Guidance for Industry and Food and Drug Administration Staff (PDF – 421KB) -September 06, 2017
- Medical Device Accessories – Describing Accessories and Classification Pathway for New Accessory Types – Guidance for Industry and Food and Drug Administration Staff (PDF – 517KB) -December 30, 2016
- Mobile Medical Applications – Guidance for Industry and Food and Drug Administration Staff (PDF – 1.3MB) -February 09, 2014
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff -January 11, 2002
- Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices (PDF – 1.4MB) -September 09, 1999
- Applying Human Factors and Usability Engineering to Medical Devices – Guidance for Industry and Food and Drug Administration Staff (PDF – 918KB) -February 03, 2016
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices – Guidance for Industry and Food and Drug Administration Staff (PDF – 324KB) -October 02, 2014
- Information for Healthcare Organizations about FDA’s “Guidance for Industry: Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) Software” -February 09, 2005
- Postmarket Management of Cybersecurity in Medical Devices – Guidance for Industry and Food and Drug Administration Staff (PDF – 1.2MB) -December 28, 2016
- Guidance for Industry and FDA Staff: Acceptable Media for Electronic Product User Manuals -March 18, 2010
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices -May 11, 2005
- Guidance for Industry: Guidance for the Submission Of Premarket Notifications for Medical Image Management Devices -July 27, 2000
- Deciding When to Submit a 510(k) for a Software Change to an Existing Device – Guidance for Industry and Food and Drug Administration Staff (PDF – 585KB) -October 25, 2017
- Guidance for Industry – Wireless Medical Telemetry Risks and Recommendations -September 27, 2000
- Deciding When To Submit A 510(k) For A Change To An Existing Wireless Telemetry Medical Device: Final Guidance for FDA Reviewers and Industry -November 30, 2000
- Radio Frequency Wireless Technology in Medical Devices – Guidance for Industry and Food and Drug Administration Staff -August 14, 2013
- Guidance for Industry and Food and Drug Administration Staff – Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Notification [510(k)] Submissions -July 03, 2012
- Guidance for Industry and FDA Staff – Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions -July 03, 2012
