Northeastern Law Faculty Affiliated with the Amy J. Reed Collaborative Petition FDA to Create a Public Database of Device Labels

Northeastern Law professors David A. Simon and Hooman Noorchashm, together with Dr. Michael Paasche-Orlow of Tufts Medical Center, who serve as co-directors of the Amy J. Reed Collaborative for Medical Device Safety (AJRC), have filed a petition with the U.S. Food and Drug Administration (FDA) requesting the creation of a database containing all labels, labeling and instructions for use of FDA-regulated medical devices.

    Northeastern Law Faculty Affiliated with the Amy J. Reed Collaborative Petition FDA to Create a Public Database of Device Labels

    02.02.26 — Northeastern Law professors David A. Simon and Hooman Noorchashm, together with Dr. Michael Paasche-Orlow of Tufts Medical Center, who serve as co-directors of the Amy J. Reed Collaborative for Medical Device Safety (AJRC), have filed a petition with the U.S. Food and Drug Administration (FDA) requesting the creation of a database containing all labels, labeling and instructions for use of FDA-regulated medical devices.

    The petition, filed January 27, builds on arguments the co-directors outlined in their recent JAMA article, “Establishing Medical Device Transparency at the FDA — A Public Database for Device Labels.” The authors argue that the FDA has both the authority and mission to maintain such a database, similar to the existing Drugs@FDA database for pharmaceutical products. While the FDA currently publishes labels for high-risk devices that receive premarket approval, it does not publish labels for the majority of moderate- to low-risk devices cleared through the less rigorous premarket notification 510(k) pathway. The AJRC states that a public database would benefit patients, clinicians and researchers by improving informed decision-making, enabling better safety signal detection and bolstering enforcement against manufacturers who fail to disclose or misrepresent risk information.

    “The current administration has promised “radical transparency,” said Simon. “Creating a database of device labels would be a meaningful, low-cost step in that direction for medical devices—and one which builds on FDA programs to do so.”.

    The petition is part of the collaborative’s broader effort to increase public transparency from the FDA’s Center for Devices and Radiological Health regarding medical devices in the United States.

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