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Medical Device Labeling Regulations; Unique Device Identification
ICR 202301-0910-017
OMB: 0910-0485
Federal Form Document
OMB.report
HHS/FDA
OMB 0910-0485
ICR 202301-0910-017
( )
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0485 can be found here:
2023-08-08 - No material or nonsubstantive change to a currently approved collection
Forms and Documents
Document
Name
Status
0485 Medical Device Labeling to add UDI 2023 SSA.docx
Supporting Statement A
2023-02-26
IC Document Collections
IC ID
Document
Title
Status
258774
Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
New
258139
Labeling requirements for UDI
New
255349
OTC Hearing Aids Final Rule - New Requirements
Other-Agency Guidance
Unchanged
255348
OTC Hearing Aids Final Rule - One Time Burden
Unchanged
ICR Details
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