Software as a Medical Device Draft Guidance Aims for Global Harmonization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.
Tag Archives: draft guidance
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The agency’s latest draft guidance is part of its strategy in creating a national evaluation system for medical devices.
FDA Releases Draft Guidance on 3-D Printed Devices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Bayer’s Next Headache: Draft Guidance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The agency issued a draft guidance that gives manufacturers information about design considerations and pre-market submissions.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.
