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U.S. Department of Health and Human Services

Medical Devices

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Article in User Facility Reporting Bulletin: "Extensions Granted to Enforcement Priorities for Reprocessed Single-Use Devices"

This article was originally published in the Medical Device User Facility Reporting Bulletin, Issue No. 35, Summer 2001 

 

EXTENSIONS GRANTED TO ENFORCEMENT PRIORITIES FOR REPROCESSED SINGLE-USE DEVICES

 

The Department of Health and Human Services has granted 6-month extensions to four reprocessors that had submitted premarket applications (PMAs) for class III single-use devices (SUD) to the Food and Drug Administration on February 14, 2001. This extension to February 14, 2002, was granted to allow the reprocessors time to obtain additional clinical information necessary for PMA approval. The extension is limited to the cardiac ablation catheter PMAs that are under current review. All other reprocessed class III SUDs may be available only under the Investigational Device Exemption (IDE) regulation

As stated in the SUD Enforcement guidance, after August 14, 2001, FDA would actively enforce the non-premarket requirements (i.e., establishment registration, device listing, medical device reporting as a manufacturer, corrections and removals, quality system requirements, labeling, and tracking). Now, FDA will actively enforce only the non-premarket requirements for hospital reprocessors to register their establishments and to list their devices with the Agency. FDA will use the additional year (until August 14, 2002) to focus on education rather than enforcement of the other non-premarket requirements for hospital reprocessors. This revised policy does not apply to the premarket requirements or to third-party (commercial) reprocessors. 

Revised Enforcement Priorities Timetable

Dates for Premarket Submissions and Approvals

 Filing DateClearance or Approval Dates:
Class III2/14/20012/14/2002*
Class II non-exempt8/14/20012/14/2002
Class I non-exempt2/14/20028/14/2002

 This new date applies only to the four class III PMAs already submitted to FDA.

Dates for Enforcement of the Non-Premarket Requirements

Establishment Registration8/14/01
Device Listing8/14/01
Quality System Regulation8/14/02
Medical Device Reporting as a manufacturer**8/14/02
Medical Device Tracking8/14/02
Labeling8/14/02
Corrections and Removals8/14/02

 **There is no change in a hospital's MDR reporting responsibilities as a user facility.