FDA Draft Premarket Guidance
The FDA has issued draft guidance for pre-market security
The FDA has issued a draft, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff. Healthcare Infosecurity has a summary and interview with Dr. Suzanne Schwartz in FDA Document Details Cyber Expectations for Device Makers. Comments are due within 90 days.