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Shelf Life of Medical Devices | FDA

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-life-medical-devices
    Shelf Life of Medical Devices April 1991 Download the Final Guidance Document Final Docket Number: FDA-2020-D-0957 Issued by: Center for Devices and Radiological Health The purpose of this...

CFR - Code of Federal Regulations Title 21 - Food and …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=801&showFR=1
    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 …

Should Medical Devices Come with Expiration Dates?

    https://www.mddionline.com/business/should-medical-devices-come-expiration-dates
    Having an expiration date available to consumers and physicians might affect their decision on how to continue using the …

Does It Expire, or Doesn’t It? Only the Manufacturer …

    https://journals.lww.com/anesthesia-analgesia/Fulltext/2014/09000/Does_It_Expire,_or_Doesn_t_It__Only_the.36.aspx
    Figure 1 shows, on the left, a sampling of items for which there was an expiration date (according to their packaging), while those on the right are selected items without an …

12 key signs and symbols on medical devices and …

    https://www.meridian-medical.com/12-key-signs-and-symbols-on-medical-devices-and-packaging/
    Indicates a medical device that needs to be protected from moisture. Product Expiry Date / Use By – this symbol will be next to the date (year/ month) on which a …

Establishing Shelf Life of Medical Devices

    https://j-pacmedical.com/pdfs/white-papers/J-pac-Whitepaper-Shelflife-Studies.pdf
    The United States Pharmacopoeia (USP) There are many things that can influence the defines shelf life (i.e. stability) as “the extent shelf life of a medical device. While the FDA …

Unique Device Identification FAQ | Philips

    https://www.usa.philips.com/healthcare/resources/landing/UDI/FAQ
    It is a new FDA regulation that all medical devices for distribution in the US be labeled with a UDI. Production Information such as a serial number, expiration date, manufacture date, …

Requirement for Expiration Date on Medical Device …

    https://elsmar.com/elsmarqualityforum/threads/requirement-for-expiration-date-on-medical-device-accessory-labeling.48880/
    As suggested before, there is no FDA requirement for an expiration date as an independent obligation. Instead an expiration date is an inherent part of the labeling …

Shelf Life of Medical Devices | Guidance Portal - HHS.gov

    https://www.hhs.gov/guidance/document/shelf-life-medical-devices
    Shelf Life of Medical Devices Final Issued by: Food and Drug Administration (FDA) Issue Date: April 01, 1991 DISCLAIMER: The contents of this database lack the …

Expiration Dates - Questions and Answers | FDA

    https://www.fda.gov/drugs/pharmaceutical-quality-resources/expiration-dates-questions-and-answers
    1. Why are expiration dates important for consumers to pay attention to? Drug expiration dates reflect the time period during which the product is known to …



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