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HHS/FDA RIN: 0910-AI59 Publication ID: Spring 2021 
Title: ●Administrative Destruction of Certain Devices Refused Admission to the United States 
Abstract:

Section 708 in the Food and Drug Administration Safety and Innovation Act (FDASIA), enacted in 2012, added FDA authority to section 801(a) of the FD&C Act to destroy any refused drug valued at $2500 or less (or such higher amount as the Secretary of the Treasury may set by regulation). To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug.

FDA proposes to amend the administrative destruction provisions in 21 CFR 1.94 to include devices in order to implement FDA’s new authority under section 2 of the Safeguarding Therapeutics Act (Pub. L. 116-304) to administratively destroy any refused device valued at $2500 or less (or such higher amount as the Secretary of the Treasury may set by regulation). These refused devices include illegal medical devices that are being imported to diagnose or treat COVID-19 such as test kits, respirators, and face masks. Other illegal devices that pose significant public health concern include illegal contact lenses.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 1.94   
Legal Authority: 21 U.S.C. 381   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  08/00/2021 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Related RINs: Related to 0910-AH12 
Agency Contact:
Ann Marie Metayer
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 32, Room 4375,
Silver Spring, MD 20993
Phone:301 796-3324
Email: ann.metayer@fda.hhs.gov