FDA Lacking Staff for New Device Approvals

23 February 2010 (Last Updated February 23rd, 2010 18:30)

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

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.