Eye on FDA

The Food and Drug Administration (FDA) has begun 2026 with a clear signal to the direct‑to‑consumer testing industry: self‑collection devices remain firmly within the agency’s regulatory reach, notwithstanding the 2025 court ruling on laboratory developed tests (LDTs). Last week, the agency published warning letters previously issued to four companies—Genetrace, Genovate, Germaphobix and ProDx Health—selling human immunodeficiency virus (HIV) tests that rely on unauthorized self‑collection kits.

In this edition of Three Questions, health care & life sciences partner Nate Brown spoke with Jeremy Schutz, director of business development, recall & remediation at Sedgwick, to explore key strategies that pharmaceutical companies and medical device manufacturers can adopt to mitigate risks related to supply chain disruptions, cybersecurity threats and increased FDA enforcement of quality control and compliance.