consistent with clarifications in FDA memo of 3-7-02 attached. This
collection has been in place without OMB approval and hence has
been in violation of the Paperwork Reduction Act. This shall be
noted in the annual Information Collection Budget.
Inventory as of this Action
Manufacturers, packers, and
distributors of medical devices are required to assure that the
labeling of the device includes adequate directions for use
according to whether the device is intended for use by health care
professionals or lay persons.