Medical devices; medical device, user facility, distributor, and manufacturer reporting, certification, and...

The Food and Drug Administration (FDA) is correcting a tentative final rule that appeared in the Federal Register of November 26, 1991 (56 FR 60024). The tentative final rule was published with some editorial errors. In the preamble under the "Paperwork Reduction Act" heading, the last two lines in the table "Estimated Annual Burden for Reporting" should have been in the table "Annual Burden for Recordkeeping". As a result, the total figures in both tables were incorrect. This document corrects the errors in these two tables.