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U.S. Department of Health and Human Services

Medical Devices

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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




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:

    1. submitted a premarket notification submission (also known as a "510(k) submission") by August 14, 2001;
    2. has not received a not substantially equivalent determination; and
    3. 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:

    1. a 510(k) submission has not been submitted to the agency by February 14, 2002, or
    2. if the class I device does not have FDA marketing clearance by August 14, 2002.

*Other than the class II and class I devices that are exempt by regulation from the 510(k) requirements of the Food, Drug, and Cosmetic Act.