View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
February 23, 2010

FDA Lacking Staff for New Device Approvals

The US Food and Drug Administration (FDA) has admitted it may need additional staff to deal with regulations and authorities handling new device approvals. At a public meeting, the FDA discussed difficulties in reviewing certain medical devices and difficulties in weighing new products

By cms admin

The US Food and Drug Administration (FDA) has admitted it may need additional staff to deal with regulations and authorities handling new device approvals.

At a public meeting, the FDA discussed difficulties in reviewing certain medical devices and difficulties in weighing new products under the accelerated review process, used for products similar to those already approved.

Difficulties in inspecting device makers and a high number of proposed new products were brought up as topics to discuss with a view to possible changes to the FDA’s device programme.

After a number of high-profile safety problems with heart defibrillators, contact lens solutions and other products raised public concerns, the FDA is weighing up potential changes to the way it evaluates medical devices.

An FDA’s task force’s recommendations will be public in June, officials said.

Critics say the accelerated process is used too widely and can lead to problems after devices are sold, according to Reuters.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Get important industry news and analysis sent to your inbox
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Hospital Management