E. General Exceptions from the Requirement for the Label of a Device To Bear a Unique Device Identifier--Broad Comments Concerning Proposed SEC 801.30
We received comments that expressed broad support for the exceptions provided by proposed
FDA disagrees with the comments that suggest we should not provide any categorical exceptions. We agree that the UDI rule should take into account both its benefits and its costs. Similarly, we do not agree that it would be best to rely entirely on case-by-case exceptions. A case-by-case approach alone would be far more burdensome than providing carefully crafted categorical exceptions, and would be more likely to result in regulatory inconsistencies and confusion that would hamper the objectives of the UDI system. However, as described in this document, we made certain changes to the exceptions in response to comments.
F. General Exceptions From the Requirement for the Label of a Device To Bear a Unique Device Identifier--Exception for a Device, Other Than a Prescription Device, That Is Made Available for Purchase at a Retail Establishment, Including Such a Device Delivered Directly to a Hospital, Ambulatory Surgical Center,
FDA received many comments (approximately 35) on this proposed exception. Roughly half of these comments requested or suggested a clarification of some aspect of the exception. For example, comments requested clarification concerning the meaning of "retail establishment," and whether the exception would apply to devices sold through any retail channel, including online, and "not simply those sold in brick-and-mortar-type stores." Other comments suggested
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