What crucial interaction is explicitly stressed in FDA guidance when establishing stability for medical devices?

Answer

Device and packaging interaction.

When establishing shelf life criteria for medical devices, regulatory expectations place specific emphasis on how the physical device material interfaces with its protective housing. FDA guidance highlights that stability—covering chemical, physical, and microbiological aspects—must account for this relationship. A key example illustrating this involves contact lens solutions, where the ratio of the solution volume to the surface area of the container is analyzed because it directly influences chemical degradation rates. Consequently, stability proof cannot be claimed for a smaller container size than the one used during the actual testing phase, underscoring the critical nature of the device-packaging system as a whole unit.

What crucial interaction is explicitly stressed in FDA guidance when establishing stability for medical devices?

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DefinitionSafetyFDAshelf liferegulation