Top

Unexplained fever? Malaria might be a possible diagnosis regardless of travel history, says CDC...

Judge’s Decision Would Make Some No-Cost Cancer Screenings a Thing of the Past

One Texas Judge Will Decide Fate of Abortion Pill Used by Millions of American Women

EU drug regulator has not found any signs of Pfizer COVID shot linking to stroke

New York nurses reach deals on third day of strike

Tag: Classification Proposed Rule

Regulatory

FDA proposes more transparent de novo pathway for medical devices

December 5, 2018

Via: medicaldevice-network.com

The De Novo pathway is used to review new, low-to-moderate risk devices and determine predicates that assure certain safety and effectiveness measures. The regulatory agency have published the new de novo Classification Proposed Rule involving procedures and criteria associated with […]

Tag: Classification Proposed Rule

FDA proposes more transparent de novo pathway for medical devices

Latest Publications

Neuronoff completes first-in-human trial for Injectrode to treat chronic pain

The Future of Human Health May Require Unlocking Access to Our Health Data

HHS finalizes reproductive health data protections

Tag: Classification Proposed Rule

FDA proposes more transparent de novo pathway for medical devices

Trending

Tags

Latest Publications

Neuronoff completes first-in-human trial for Injectrode to treat chronic pain

The Future of Human Health May Require Unlocking Access to Our Health Data

HHS finalizes reproductive health data protections