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Date: | Fri, 15 Mar 2019 13:50:44 -0400 |
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In "Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with
Drugs and Biological Products Testing" it states that functional testing of syringe drug/biologic products may be required at submission which includes safety features (safety device) testing.
I do not see post-marketing stability requirements for mechanical testing of the safety device of syringe products. Does anyone know if there are post-marketing stability requirements for safety device testing? Does anyone include safety device testing in their annual stability program for syringe products?
https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM147095.pdf
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