Nonconcurrent Control Use in FDA Approval of High-Risk Medical Devices

What the paper explores

This cross-sectional analysis examined nonconcurrent controls in pivotal studies supporting high-risk therapeutic device approvals. The authors reviewed the use of historical controls, objective performance criteria and performance goals, together with the explanations and clinical detail made available in public records.

How to interpret the evidence

The analysis reflects the information reported publicly. It cannot recover all discussions or data in a regulatory review, and it does not establish that a nonconcurrent design is unsuitable in every setting.

Questions for MedTech teams

When considering an external comparator, document its origin, clinical relevance, patient comparability and assumptions before the analysis begins.