Medical devices; medical device, user facility, distributor, and manufacturer reporting, certification, and registration; correction--FDA. Tentative final rule; correction.
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.
D003365:Costs and Cost Analysis; D004869:Equipment Safety / Q000592:standards*; D005568:Forms and Records Control / Q000331:legislation & jurisprudence*; D006268:Health Facilities / Q000331:legislation & jurisprudence; D007221:Industry / Q000331:legislation & jurisprudence; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration