The draft provides suggestions on device design, labeling and documentation that should be included in premarket submissions.
The document aims to clear up how the agency looks at device functions that aren’t subject to premarket review of safety and effectiveness.
FDA offers help on when and what type of clinical evaluation is appropriate for SaMD.
The agency’s latest draft guidance is part of its strategy in creating a national evaluation system for medical devices.
The agency addresses design and manufacturing considerations, along with device submissions for product approval.
In terms of risk mitigation, FDA misses the boat here.
The agency issued a draft guidance that gives manufacturers information about design considerations and pre-market submissions.
With the goal of acting as a single agency, FDA’s OCP has several activities planned for this year.