The guidance seeks to balance the need to obtain data on the safety and effectiveness of drugs, biological products and medical devices in the pediatric population with risks associated with exposure to such products and the reality that children cannot themselves consent to take part in research.
The new guidance is intended to establish confidence in automation used for production or quality assurance systems and describe various methods and testing activities that may be applied to establish computer software assurance and meet regulatory software validation requirements.
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The agency’s latest draft guidance is part of its strategy in creating a national evaluation system for medical devices.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The agency issued a draft guidance that gives manufacturers information about design considerations and pre-market submissions.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.
