0910-AH48 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies to be Allowed in Electronic Format

The Food and Drug Administration (FDA or Agency) is amending its regulations to remove requirements to submit multiple paper copies of medical device regulatory pre-submissions and submissions and replace them with one copy in an electronic format. We are revising premarket submissions and registration and listing regulations to make an efficient and effective electronic submission program.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage Undetermined No Deregulatory 21 CFR 807 21 CFR 812 21 CFR 814 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 to 353 21 U.S.C. 355 21 U.S.C. 360 21 U.S.C. 360h to 360j 21 U.S.C. 371 and 372 21 U.S.C. 374 and 375 21 U.S.C. 379 21 U.S.C. 379e 21 U.S.C. 381 21 U.S.C. 382 21 U.S.C. 393 21 U.S.C. 745A 42 U.S.C. 216 42 U.S.C. 241 42 U.S.C. 262 42 U.S.C. 263b to 26n 42 U.S.C. 264 42 U.S.C. 271 No Direct Final Rule 05/00/2018 No No None No No No No Madhusoodana Nambiar Policy Advisor 0910 Food and Drug Administration FDA 301 796-5837 madhusoodana.nambiar@fda.hhs.gov 10903 New Hampshire Avenue, Building 66, Room 5519, Silver Spring MD 20993