FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.

FDA ACTIONS ON REPROCESSED SINGLE USE DEVICES

The Food and Drug Adminstration (FDA) has notified four reprocessors of single-use ablation catheters that the agency does not intend to enforce premarket requirements for their catheters until February 14, 2002. These reprocessors submitted premarket applications to comply with the premarket approval requirements FDA announced in its strategy on August 14, 2000, to actively enforce all regulatory requirements for reprocessors of single use devices.

FDA issued its announcement about the extended grace period for premarket approval in response to a manufacturer's request for more time to complete ongoing studies for its premarket application. FDA agreed that allowing more time for completion of studies was reasonable, and provided the four cardiac catheter manufacturers an additional six months to FDA's original deadline of August 14, 2001, to comply with FDA approval requirements.

In response to concerns about reprocessed single use devices, FDA announced last year that it intended to phase in active enforcement of all its premarket and postmarket requirements for devices to ensure that the cleaning, disinfecting, and sterilization of reprocessed single-use devices afforded the same level of safety and effectiveness for patients as those who receive new ones. FDA's enforcement of its premarket requirements for hospital and third party reprocessors is planned to be implemented at several different stages depending on the risk categorization of a device as Class I, II, and III.

Class III devices are the most highly regulated, such as the cardiac ablation catheters which are used in procedures to treat irregular heartbeats. With the exception of the cardiac catheters for which FDA has extended the enforcement discretion period, FDA is now actively enforcing premarket approval requirements for all reprocessed class III devices. These devices may only be made available as unapproved investigational devices with informed consent.

Class II devices are moderate risk devices. An example of a class II device is a cardiac mapping catheter used to map electrical activity of the heart. FDA intends to enforce premarket filing requirements for reprocessed Class II devices as of August 14, 2001, and marketing clearance requirements on February 14, 2002.

Class I devices are low risk devices. An example of a class I device is an orthopedic surgical drill. FDA intends to enforce premarket filing requirements for reprocessed Class I devices as of February 14, 2002, and marketing clearance requirements on August 14, 2002.

Postmarket requirements, such as registration, listing, medical device reporting, medical device tracking, medical device corrections and removals, the quality system regulation, and labeling are also applicable to third party and hospital reprocessors. In contrast to FDA’s policies concerning premarket requirements, however, FDA has always actively enforced postmarket requirements for third party reprocessors. Historically, FDA has not actively enforced these requirements for hospital reprocessors.

Last year, FDA announced a phased in enforcement strategy for postmarket requirements for hospital reprocessors. As of August 14, 2001, FDA is actively enforcing registration and listing requirements for hospital reprocessors, but intends to use the next year to focus on education rather than enforcement of the additional postmarket requirements for hospital reprocessors.

More information about FDA’s regulation of reprocessed single-use devices is available online at http://www.fda.gov/cdrh/reuse/index.shtml.

FDA News Page   |   FDA Home Page

Office of Public Affairs
Hypertext uploaded by jch 2001-AUG-16.