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HHS/FDA RIN: 0910-AH48 Publication ID: Spring 2018 
Title: 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.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
CFR Citation: 21 CFR 807    21 CFR 812    21 CFR 814   
Legal Authority: 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   
Legal Deadline:  None
Action Date FR Cite
Direct Final Rule  05/00/2018 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Madhusoodana Nambiar
Policy Advisor
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 66, Room 5519,
Silver Spring, MD 20993
Phone:301 796-5837