FDA pledges support for med tech initiative

(AP)—The Food and Drug Administration says it will collaborate with medical device manufacturers on a public-private partnership designed to speed up the development of new medical technology.

The agency says it hopes to offer guidance to the Medical Device Innovation Consortium, a new industry-backed group that aims to simplify the design and testing of medical devices.

Medical device makers have criticized the FDA for an overly burdensome review process, which they claim slows down development of important new therapies. Congressional Republicans have held several hearings to scrutinize the agency's system.

Faced with criticism from industry and Capitol Hill, the FDA has been highlighting efforts to slash red tape and accelerate review times.

The new consortium was created by LifeScience Alley, a Minnesota-based industry group that includes leading manufacturer Inc.

0 shares

Related Stories

FDA aims to accelerate medical device reviews

date Feb 08, 2011

(AP) -- Federal health officials have proposed a plan that would speed up the approval of innovative medical devices that hold the potential to dramatically improve patients' lives.

FDA plans modest changes to medical device system

date Jan 19, 2011

(AP) -- The Food and Drug Administration is laying out plans to update the 35-year-old system used to approve most medical devices, which has been subject to increasing criticism by public safety advocates.

FDA medical device approvals get external review

date Sep 23, 2009

(AP) -- The Food and Drug Administration is asking the government's top medical advisers to review its system for approving certain types of medical devices, which has been criticized by safety advocates and government watchdogs.

FDA moves toward tighter medical device oversight

date Aug 04, 2010

(AP) -- Makers of X-ray machines, drug pumps and other medical devices would have to submit more safety information to win federal approval under a proposal designed to tighten regulation of thousands of products reviewed ...

Recommended for you

Rising antibiotic shortages raise concerns about patient care

date Apr 23, 2015

Shortages of key antibiotics, including gold-standard therapies and drugs used to treat highly resistant infections, are on the rise, according to a new study of shortages from 2001 to 2013 published in Clinical Infectious Di ...

Study supports HPV vaccination guidelines

date Apr 21, 2015

(HealthDay)—New research finds that young women who get the HPV vaccine gain significant protection against infection in three parts of the body if they haven't already been exposed to the human papillomavirus.

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.