Nov 18, 2011

The US Food and Drug Administration is requesting comment on its information collection practices regarding medical device recall policies.

The FDA’s device recall process, authorized by US federal law, consists of three steps:

  1. If a reasonable probability exists that a device would cause patient harm or death, the agency may issue a cease distribution and notification order mandating that relevant entities stop distribution of the device, notify health providers and facilities of the FDA order, and instruct all health professionals and facilities to stop using the device.
  2. People named in an FDA cease distribution and notification order will be granted an informal hearing to consider whether the order should be modified, vacated or amended to require a mandatory device recall.
  3. Following the informal hearing, the FDA has the option of issuing a mandatory recall of a device.

Data collected by the FDA under device recall authority provisions is used to ensure safety and effectiveness of devices entering the US market, detect serious issues with devices, and remove defective or dangerous devices from the market.

The agency sees no substantial operational, capital or maintenance costs associated with gathering the information necessary for voluntary or mandatory device recalls. However, the agency is seeking feedback from industry regarding ways to enhance data collection related to device recalls without causing undue regulatory burdens for companies involved.

Firms have until January 17, 2012 to comment.


  • Stewart Eisenhart