Article in User Facility Reporting Bulletin: Changes in Enforcement Deadline for Reprocessed Class II Single -Use Devices
This article was originally published in the Medical Device User Facility Bulletin, Issue No. 37, Winter 2001
CHANGE IN ENFORCEMENT DEADLINE FOR
REPROCESSED CLASS II SINGLE-USE DEVICES
The Food and Drug Administration (FDA) announced on February 14, 2002, a change in the enforcement deadline for class II reprocessed single-use devices (SUD) and reminded hospital SUD reprocessors of the agency's enforcement policy for premarket requirements as follows:
Class II Devices*
FDA is extending the deadline for active enforcement of premarket notification submission requirements for class II SUDs until August 14, 2002, provided that the reprocessor:
- submitted a premarket notification submission (also known as a "510(k) submission") by August 14, 2001;
- has not received a not substantially equivalent determination; and
- provides timely responses to FDA's requests for additional information per 21 CFR §807.87(l).
Class III Devices
FDA may actively enforce premarket approval requirements for class III SUDs on February 14, 2002.
Class I Devices*
FDA may take enforcement action against any class I SUD if:
- a 510(k) submission has not been submitted to the agency by February 14, 2002, or
- if the class I device does not have FDA marketing clearance by August 14, 2002.