FDA's New Communications and Compliance Tool for Device Data Integrity Concerns

On February 3, 2026, the Consolidated Appropriations Act, 2026 (P.L. 119-75) became law and marked an important milestone in the bipartisan congressional effort to reauthorize the rare pediatric disease priority review voucher program. Section 6604 of this law extends the Food and Drug Administration’s (FDA) authority to issue priority review vouchers to encourage treatments for rare pediatric diseases through September 30, 2029.

In case you missed it, Department of Health and Human Services Secretary Robert F. Kennedy Jr. and former Food and Drug Administration (FDA) Commissioner David Kessler appeared on 60 Minutes this past Saturday, February 15, in a segment titled “Generally Recognized as Safe.” As the title suggests, the conversation centered on FDA’s Generally Recognized as Safe (GRAS) regulatory pathway (for background, see our prior post discussing in more detail the GRAS process), as well as Commissioner Kessler’s August 2025 citizen petition urging FDA to revoke the GRAS status of refined carbohydrates used in industrial food processing (discussed in more detail in our earlier coverage of the petition).

On February 1, 2026, the Food and Drug Administration (FDA) officially started accepting requests to participate in the FDA PreCheck pilot program. The goal of the program is to strengthen the domestic pharmaceutical supply chain by making the review and inspection process more predictable for U.S.-based drug manufacturing facilities.

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.