Existing Wording: The Human Readable Form (HRF) representation of the barcode string as printed on the packaging of the device SHALL be used. The AIDC representation cannot be conveyed in FHIR, Because of limitations on character sets in XML and the need to round-trip JSON data through XML.

Proposed Wording: The Human Readable Form (HRF) representation of the barcode string as printed on the packaging or thee AIDC representation MAY be conveyed in addition to the mandatory data elements: (A) Device Identifier; and

(B) The following identifiers that compose the Production Identifier:

(1) The lot or batch within which a device was manufactured;

(2) The serial number of a specific device;

(3) The expiration date of a specific device;

(4) The date a specific device was manufactured; and

(5) For an HCT/P regulated as a device, the distinct identification code required by 21 CFR 1271.290(c)."

Comment:

The current language describes limitations that don't exist in R3 or R4.

Summary:

Update conformance text for us-device-core to reflect the R3 Device and MU2015 certification criteria.