FF. Technical Standards Applicable to Part 830--
FDA received four comments on this provision, which incorporates by reference the technical standards essential to the UDI system.
Two comments suggested
These same (or very similar) comments and issues are discussed earlier in this document; see section II.
A comment suggested
FDA declines to accept this suggestion as doing so would impermissibly allow the standards organizations to change regulatory requirements without going through notice-and-comment rulemaking.
GG. Requirements for a Unique Device Identifier--
FDA received six comments on this section.
Three comments recommended that
These comments repeat comments discussed earlier in this document; see section II.
As explained in section II. S.,
One comment suggested that UDI "codes" should be standardized by device type, and not be "randomly assigned." A similar comment stated, "The database would be more useful if specific field lengths were reserved for specific fields. Specifically we mean, reserve (for example) the first 12 characters for the 'Device Identifier' and characters 13-24 (for example) for the [Production Identifier]. Consider also dividing that number out into space for batch, date, etc."
FDA does not agree with either of these comments. Under the system provided by this rule, each
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