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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...
Expiration Dates - Questions and Answers | FDA
- https://www.fda.gov/drugs/pharmaceutical-quality-resources/expiration-dates-questions-and-answers
- Under the Shelf-Life Extension Program (SLEP), FDA conducts testing for certain products stored in federal stockpiles in environmentally controlled locations. …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=803.3
- (h) Five-day report means a medical device report that must be submitted by a manufacturer to us under § 803.53 within 5 work days. (i) Hospital means a distinct …
Medical Devices | FDA - U.S. Food and Drug Administration
- https://www.fda.gov/Medical-Devices
- FDA Issues Two Warning Letters to Leading Manufacturer of Endoscopes CDRH recently issued two warning letters to a leading manufacturer of endoscopes, Olympus Medical …
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