Medical Device Labeling Regulations; Unique Device Identification

ICR 202301-0910-017

⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0485 can be found here:

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