Expiration Date Medical Devices Fda

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...

At-Home OTC COVID-19 Diagnostic Tests | FDA

https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests

The table below lists FDA-authorized at-home OTC COVID-19 diagnostic tests, and includes information on expiration dates, who can use the test, and other …

Expiration Dates - Questions and Answers | FDA

https://www.fda.gov/drugs/pharmaceutical-quality-resources/expiration-dates-questions-and-answers

FDA’s guidance for industry, “ Changes to an Approved NDA or ANDA ” explains that the manufacturer of an approved drug product may extend the expiration …

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 the user …

Expiration Dating Extension | FDA

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/expiration-dating-extension

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=801.18

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 801.18 Format of dates provided on a medical …

Quality System Regulation Labeling Requirements | FDA

https://www.fda.gov/medical-devices/device-labeling/quality-system-regulation-labeling-requirements

There may be a need for expiration dating when a particular component of a device, such as a battery or diagnostic reagent, has a finite useful life. Labeling for in vitro diagnostic …

eCFR :: 21 CFR 801.18 -- Format of dates provided on a …

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-A/section-801.18

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 …

Sterilization for Medical Devices | FDA

https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices

On June 7, 2022, the FDA announced it was considering a master file pilot program for premarket approval (PMA) holders whose approved devices are sterilized …

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

Stay up to date as we continue to keep up our ongoing mission of protecting public health and spurring medical device innovation. "Our center and the entire FDA stand ready to …