FDA’s Draft Guidance Lays Out Recommendations for Medical Devices with Cybersecurity Risks
The draft provides suggestions on device design, labeling and documentation that should be included in premarket submissions.
Tag Archives: draft guidance
FDA Releases Draft Guidance for Multiple Function Devices
The document aims to clear up how the agency looks at device functions that aren’t subject to premarket review of safety and effectiveness.
Software as a Medical Device Draft Guidance Aims for Global Harmonization
FDA offers help on when and what type of clinical evaluation is appropriate for SaMD.
FDA Explains Role of Real-World Evidence in Regulatory Decisions
The agency’s latest draft guidance is part of its strategy in creating a national evaluation system for medical devices.
FDA Releases Draft Guidance on 3-D Printed Devices
The agency addresses design and manufacturing considerations, along with device submissions for product approval.
Bayer’s Next Headache: Draft Guidance
In terms of risk mitigation, FDA misses the boat here.
FDA Helps Manufacturers Address Security and Risk of Interoperable Medical Devices
The agency issued a draft guidance that gives manufacturers information about design considerations and pre-market submissions.
FDA: Developing Combination Products Requires Consistency, Transparency, Collaboration
With the goal of acting as a single agency, FDA’s OCP has several activities planned for this year.
