What does an expiration date printed on a medical device specifically mark regarding its shelf life?
Answer
The termination of that shelf life.
For medical devices, shelf life is defined as the specific duration during which the item retains its stated safety characteristics and intended function, provided it is stored exactly as specified by the manufacturer. The expiration date affixed to the device packaging serves as a clear demarcation line indicating the end of this guaranteed functional period. Once this date passes, the manufacturer's assurance regarding the device's performance is no longer in effect. Unlike drugs where potency is the central concern, device shelf life termination signifies that the potential for functional failure or compromise of sterility has reached an unacceptable level.
Related Questions
How is the Labeled Shelf Life for a drug defined according to stability working groups?Which category of stability criteria addresses changes in measurable characteristics like elasticity or tensile strength for medical devices?For most food products regulated by the FDA and FSIS, dating primarily indicates quality, but what is the primary exception mandated by this distinction?What must drug applicants submit to the FDA to support a proposed expiration date and storage conditions?Which statistical methodology for drug shelf life estimation is often dictated by the "worst-case" batch in a stability study?What crucial interaction is explicitly stressed in FDA guidance when establishing stability for medical devices?What are identified as the primary enemies post-purchase for commercially sealed, shelf-stable goods managed by consumers?What term describes the actual, but unknowable, storage time a drug product will remain fit for use and effective?What does an expiration date printed on a medical device specifically mark regarding its shelf life?Which universal factor dictating shelf life across drugs, devices, and food includes variables like humidity and light exposure?