J&J metal hip trial stirs up renewed call for 510(k) reform

Metal-on-metal implant--courtesy of NIH

A San Francisco Chronicle story renews calls for the FDA to close loopholes that allow devices such as all-metal artificial hips to win 510(k) clearance, and avoid human testing before approval as a result. The argument comes in the context of thousands of lawsuits over ASR brand hips made by Johnson & Johnson ($JNJ)/DePuy, many of which released tiny metal fragments and led to patient health problems. An initial trial focused on the DePuy hip began recently in a Southern California court, the article notes, and thousands of lawsuits are pending. The idea is that closing the loophole that allowed all-metal hips to obtain 510(k) clearance without human trials would prevent similar problems in the future, and the story highlights hip implant patients who suffered without such a provision in place. Story

Sponsored By Metabolon

Five Translational Insights Key to a Successful First-in-Human (FIH) Study – Metabolite-Based Biomarker Discovery and Validation

Translational success rates from pre-clinical animal studies to human clinical trials remain frustratingly low. Learn how metabolomics helps you bridge between the theoretical & practical, between the function & actual activity of your drug molecule to get you closer to the phenotype, sooner.