21 CFR 801.18 -- Format of dates provided on a medical device …
Whenever the label of a medical device includes a printed expiration date, date of manufacture, or any other date intended to be brought to the attention of the user of the device, the date must be presented in the following format: The year, using four digits; followed by the month, using two digits; followed by the day, using two digits; each ...
eCFR :: 21 CFR Part 801 -- Labeling
Whenever the label of a medical device includes a printed expiration date, date of manufacture, or any other date intended to be brought to the attention of the user of the device, the date must be presented in the following format: The year, using four digits; followed by the month, using two digits; followed by the day, using two digits; each ...
CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
Dec 24, 2024 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Note: If you need help accessing information in different file formats, see Instructions...
UDI Compliance Policies and UDI Rule Compliance Dates | FDA
Devices labeled on or after September 24, 2023, must comply with all applicable UDI requirements, including the prohibition on the use of certain legacy FDA identification numbers (National...
Expiration Dates - Questions and Answers | FDA - U.S. Food and Drug …
Jan 21, 2025 · FDA regulations require drug applicants to provide stability testing data with a proposed expiration date and storage conditions when they submit an application for FDA approval of their drug.
FDA’s unique device identification system (UDI system) is designed to adequately identify devices through distribution and use.1Its requirements were designed to be phased in over seven years...
21 CFR 610.50 -- Date of manufacture for biological products.
The dating period for a product must begin on the date of manufacture as described in paragraphs (b) and of this section. The dating period for a combination of two or more products must be no longer than the dating period of the component with the shortest dating period.
CFR - Code of Federal Regulations Title 21 - accessdata.fda.gov
Whenever the label of a medical device includes a printed expiration date, date of manufacture, or any other date intended to be brought to the attention of the user of the device, the date must be...
Food Product Dating - Food Safety and Inspection Service
Nov 30, 2023 · Federal regulations require a "Use-By" date on the product label of infant formula under inspection of the U.S. Food and Drug Administration (FDA). Consumption by this date ensures the formula contains not less than the quantity of each nutrient as described on the label.
FDA Date Format Requirement - Elsmar Cove Quality and …
May 14, 2019 · Historically FDA had a date format requirement of spelled out month, then date, then four digit year. Now with UDI and EU it seems that the standardized date format for those entities is four digit year, hyphen, two digit month, hyphen, two digit day.