Coverage
News & Opinion
Curated reporting, peer-reviewed research, and expert commentary on the 510(k) regulatory system — from watchdog groups, academic journals, and investigative journalists.
Identification of Predicate Creep: A Case Study of a Robotic Surgical Device
Lefkovich & Rothenberg (2023) trace 2,618 device instances across 15 product codes in the Da Vinci Si Surgical System, finding evidence of both large- and small-scale predicate creep. Proposes a new product-code methodology for identifying predicate chains. DOI: 10.1371/journal.pone.0283442
Read full paper →The Danger Within Us: America's Untested, Unregulated Medical Device Industry
Investigative journalist Jeanne Lenzer exposes systemic FDA oversight failures through the case of Dennis Fegan, whose implanted device nearly killed him. Marcia Angell (former NEJM editor-in-chief): "Lenzer exposes the web of commercial incentives governing their use, and the refusal of manufacturers and the FDA to take responsibility when things go wrong." ★★★ Starred reviews: Library Journal, Booklist, Publishers Weekly.
View on Amazon →Medical Device Industry at a Crossroads: Will Industry Profits Trump Patient Safety?
Public Citizen investigates the political economy of 510(k) reform — documenting industry lobbying efforts and the regulatory capture that has kept a flawed system in place for decades.
Read article →Medical Device Industry Lobbying: A BMJ Investigation
The British Medical Journal investigates how the medical device industry funds lobbying efforts to maintain favorable regulatory conditions, with particular focus on maintaining the 510(k) pathway as the dominant clearance mechanism.
Read paper →The Medical Device Amendments of 1976: The Statute That Went Awry
A legal analysis of how the 1976 Medical Device Amendments created the 510(k) pathway as a temporary grandfather clause — and how it evolved into the dominant clearance mechanism against the intent of its drafters.
Read →FDA Cleared vs. Safe: The 510(k) Medical Device Loophole
Plain-language explanation of the critical legal and practical distinction between "FDA cleared" and "FDA approved" — and what that difference means for patient safety and device manufacturers' liability.
Read →The Bleeding Edge
Netflix documentary examining the medical device industry's lack of oversight and the patients harmed by devices cleared through the 510(k) pathway. Recommended companion viewing to Jeanne Lenzer's book The Danger Within Us.
Watch on YouTube →An Introduction to FDA's Regulation of Medical Devices
Official FDA training video from the CDRH Third-Party Reviewer Curriculum. Elias Mallis provides a high-level overview of regulatory requirements — 510(k), PMA, IDE — and the steps to bring a new device to market.
Watch video →Government Accountability Office Finds Holes in FDA's Device Oversight
ABC News coverage of a Government Accountability Office report finding significant gaps in FDA's ability to oversee medical devices — a key document cited in congressional hearings on 510(k) reform.
Read →From Clearance to Clinic: Understanding FDA 510(k) Clearance Pathway and Patient Risk
A continuing medical education resource board compiling literature, keynote content from Jeanne Lenzer and former FDA Commissioner David Kessler, the full FDA Third-Party Reviewer Training Curriculum, and recalled device case studies.
View resource board →"Medical interventions have become the third leading cause of death in America. The overwhelming majority of high-risk implanted devices have never undergone a single clinical trial."Jeanne Lenzer — The Danger Within Us (2017)