FDA Traces A New Device Approval Path
FDA Traces A New Device Approval Path

According to the reports, the Food and Drug Administration of US has proposed a new way for breakthrough medical devices to be approved by the agency.

On Tuesday, in a briefing agency officials said that a new Innovation Pathway is part of an initiative designed to help cutting-edge products win quicker clearance than earlier.

“The new pathway isn't an ordinary proposal and not the usual from a regulatory agency", said FDA device Chief Dr. Jeffrey Shuren. According to Shuren, the new initiative is like "a sea change in the way we approach public health."

Ubl, a Minnesota native said, "We believe it is critical that FDA maintain its focus on bringing greater speed and consistency to the current review process. The problems with the process "needlessly delay patient access to life- saving, life-enhancing medical technology."

New Brighton based Acorn raised around $110 million to develop a novel device to treat heart failure. However, it has failed to gain FDA approval after a decade of wrangling with the agency.

According to The new Innovation Pathway, the FDA will get involved early with companies developing a novel product. This program would be used for a relatively small subset of medical devices, which provide significant improvement over current treatments.

Latest News

Indian-origin doctor jailed for death of woman
Britain's fattest teenager, tragic 63st Georgia Davis, refused to board vital fl
Scientists Suggest to Rise Prices of Caffeinated Drinks
Ontario’s Fight to Cut Spending Concerns Health Care Costs
Flesh eating bacteria affected Woman on Recovery Track
Women Outweigh Men in Food Shopping
2nd Heart Transplant Rejection Claims Teenager’s Life
Pom Wonderful Comes out with a New Ad Campaign after Court’s Ruling
Women Not Provided With Vital Information Relating To Infertility
Kids Confusing Tiny Detergent Packs With Toys
Dragon Becomes 1st Private Spacecraft
NASA Worried over Lunar History