Hello Lee,
As the others have said, it is really up to the company and referred to in the guidance leaving it up to the Manufacturer to determine if a shelf-life (or expiration date maybe) is needed for non-sterile products. If the product can degrade, deteriorate, or usability is affected over time through storage, transport, use, or reprocessing, really is left up to the Manufacturer to determine this ... and state this as part of the specification related to the product. This is also inferred in the General Safety and Performance Requirements (GSPR) of the EU MDR/EU IVDR as well that a shelf-life, expiration date, or useable life of a product needs to be determined by the Manufacturer - which in some cases would not be applicable. While in the United States a justification can be written, it is quite expected in the European Union a life of device needs to be assigned to all medical devices.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 13-Mar-2023 22:17
From: Kevin Randall
Subject: Requirement for Expiration Date on non-sterile device
In alignment with 801.18, FDA's shelf life guidance states, "...To determine if a particular device requires a shelf life and assign an expiration date, there are a number of different parameters that must be considered....For some devices...it is not reasonable to assign a shelf life..." [emphasis added.].
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 13-Mar-2023 19:40
From: Lee Leichter
Subject: Requirement for Expiration Date on non-sterile device
I know I have seen, but I cannot locate, some previous discussions on this topic. I can see in the GMPs and labeling regulations have statements that make it clear that there expiration dates are not required, such as 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... and 820.120 (b) Labeling inspection. Labeling shall not be released for storage or use until a designated individual(s) has examined the labeling for accuracy including, where applicable, the correct unique device identifier (UDI) or universal product code (UPC), expiration date,
However, the FDA Shelf Life of Medical Devices guidance, without citing a requirement, implies that there must be a date assigned.
Does anyone have a specific reference that provides that an expiration date is not required and/or a specific exception for GMP exempt products.
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Lee Leichter RAC
President
Fort Denaud FL
United States
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