United States Regulatory

UNIQUE DEVICE IDENTIFICATION RULE

REGULATORY AGENCY	UNITED STATES Food and Drug Administration (FDA)
REGULATION NAME	Unique Device Identification Rule
COMPLIANCE DATES	Timeframe: Final Rule: September 24th 2013 UDI System Final Rule Date w/ draft U.S. FDA GUDID guidance September 24th 2014 Class III and CBER blood screening IVD deadline (including Class III standalone software) September 24th 2015 Compliance deadline for life supporting/ life-sustaining and extension expiration for Class III and blood screening September 24th 2016 Class II products compliance deadline and Class III direct mark deadline (for products to be used more than once and reprocessed between uses) – UDI marking only NOT GUDID September 24th 2018, Class II direct mark deadline (used more than once and reprocessed between uses) September 24th, 2020 Implantable, life-supporting, or life-sustaining class I and unclassified devices September 24th 2022 Rest of Class I and unclassified + direct marking (used more than once and reprocessed between uses) Direct marking requirement follow each timeline by +2 years
APPLIES TO	This applies only to finished class III, LS/LS, and class II devices that are non-sterile, that were manufactured and labeled prior to their established direct mark compliance date, and that remain in inventory. This is intended to alleviate manufacturers of having to rework finished devices.

PRIMARY PACKAGING

(Packaging which is in direct physical contact with the active ingredient)

BARCODE SYMBOLOGY	GS1 DataMatrix (inter alia, ID/linear bar code, 2D/Matrix bar code, RFID)
BARCODE CONTENTS	GTIN (AI 01) Expiry Date (AI 17) Batch Number (AI 10) Serial Number (AI 21)
SERIAL NUMBER RANDOMIZATION	NA
SERIAL NUMBER REUSE	No
HUMAN READABLE EXPIRY DATE FORMAT	YYMMDD
BARCODE DATA ENCODING	UDI – PI
FREE SAMPLES MUST BE MARKED?	Primary Level Packaging Is defined as the first level of packaging in direct contact with the product and marked with an AIDC (Automatic Identification and Data Capture) data carrier either on the packaging or on a label affixed to the packaging. It may consist of a single item or group of items for a single therapy such as a Kit. For packaging configurations that include a retail consumer trade item, primary packaging is a packaging level below the retail consumer trade item.
FREE SAMPLES MUST BE MARKED?	Not Specified

SECONDARY PACKAGING

(A carton containing one or more primary packs and includes a “mono carton” containing one primary pack)

BARCODE SYMBOLOGY	GS1 DataMatrix (inter alia, ID/linear bar code, 2D/Matrix bar code, RFID)
BARCODE CONTENTS	GTIN (AI 01) Expiry Date (AI 17) Batch Number (AI 10) Serial Number (AI 21)
SERIAL NUMBER RANDOMIZATION	NA
SERIAL NUMBER REUSE	No
HUMAN READABLE EXPIRY DATE FORMAT	YYMMDD
BARCODE DATA ENCODING	UDI – PI
PRODUCT CODE NOTES	Due to the wide variety of secondary level packaging configurations for medical devices, following is additional guidance. In the following examples, the outer carton is the secondary level packaging. One device packaged in primary level packaging contained in a single outer carton. A collection of more than one of the same medical device, each packaged in primary level packaging, contained in a single outer carton (includes shelf packs). Multiple, different medical devices intended for one therapy packaged in a single tray, and that single tray contained in a single outer carton (may also be referred to as a Kit). Multiple, different medical devices intended for one therapy packaged in a single tray, and several of those trays are contained in a single outer carton (may also be referred to as a Kit)
FREE SAMPLES MUST BE MARKED?	No

TERTIARY PACKAGING

(A shipper containing one or more secondary packs)

BARCODE SYMBOLOGY	SSCC
BARCODE CONTENTS	GS1-128 (SSCC)

AGGREGATION DATA CAPTURE

PARENT-CHILD MAPPING AGGREGATION CAPTURE?

Yes

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	Yes (GUDID :- The Global Unique Device Identification Database )
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND UNIT DATA TO TRADING PARTNER?	As applicable
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?	Yes
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND AGGREGATION DATA TO TRADING PARTNER?	As applicable

AUTHENTICATION

WHO OFFERS DATA REPOSITORY FOR AUTHENTICATION?	FDA : Food and Drug Administration
MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY?	Yes (Exports & Import)
DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT?	Yes
DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT?	Yes

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?	Yes
DOWNSTREAM TRADING PARTNER ACTIVITY REPORTED?	Yes

US DRUG SUPPLY CHAIN SECURITY ACT (DSCSA)

REGULATORY AGENCY	UNITED STATES Food and Drug Administration (FDA)
REGULATION NAME	The Drug Supply Chain Security Act (DSCSA)
COMPLIANCE DATES	Over Due Deadline: - 1 January 2015: Lot number, - November 2017: Serialized product identifiers (delayed for one year, see FDA– 2017-D-2232) Upcoming Deadline: - November 2023: Pkg (item-level) traceability
APPLIES TO	Drug manufacturers, re-packagers, wholesale distributors, and dispensers. “Dispensers” include any company that is authorized to dispense or administer prescription drugs to patients. Third-party logistics providers also have new requirements.

PRIMARY PACKAGING

(Packaging which is in direct physical contact with the active ingredient)

BARCODE SYMBOLOGY	2D Bar Code : GS1 DataMatrix
BARCODE CONTENTS	The machine-readable portion of the “product identifier” consisting of: Standardized numerical identifier (SNI) (made up of the 10-digit NDC and serial number up to 20 characters) or GTIN Lot number Expiration date of the product The 10-digit NDC contained in the barcode may be encoded into a GS1 GTIN
SERIAL NUMBER RANDOMIZATION	NA
SERIAL NUMBER REUSE	No
HUMAN READABLE EXPIRY DATE FORMAT	YYMMDD
BARCODE DATA ENCODING	GS1 Standard
Product Code Notes	According to FDA’s SNI guidance from 2010, SNI’s can be generated using GS1 standards, or ICCBBA standards for certain biological products. When using GS1 standards, the NDC may be encoded within a GS1 GTIN structure for the purpose of generating the barcode. The DSCSA “Product Identifier” includes the human readable contents, which must reflect the data contents of the barcode. See guidance from the Healthcare Distribution Alliance for properly marking product and cases with the DSCSA product identifier
FREE SAMPLES MUST BE MARKED?	No

SECONDARY PACKAGING

(A carton containing one or more primary packs and includes a “mono carton” containing one primary pack)

BARCODE SYMBOLOGY	2D Bar Code : GS1 DataMatrix
BARCODE CONTENTS	The machine-readable portion of the “product identifier” consisting of: Standardized numerical identifier (SNI) (made up of the 10-digit NDC and serial number up to 20 characters) or GTIN Lot number Expiration date of the product The 10-digit NDC contained in the barcode may be encoded into a GS1 GTIN
SERIAL NUMBER RANDOMIZATION	NA
SERIAL NUMBER REUSE	No
HUMAN READABLE EXPIRY DATE FORMAT	YYMMDD
BARCODE DATA ENCODING	GS1 standard
PRODUCT CODE NOTES	According to FDA's SNI guidance from 2010, SNI's can be generated using GS1 standards, or ICCBBA standards for certain biological products. When using GS1 standards, the NDC may be encoded within a GS1 GTIN structure for the purpose of generating the barcode. The DSCSA “Product Identifier” includes the human readable contents, which must reflect the data contents of the barcode. See guidance from the Healthcare Distribution Alliance for properly marking product and cases with the DSCSA product identifier
FREE SAMPLES MUST BE MARKED?	No

TERTIARY PACKAGING

(A shipper containing one or more secondary packs)

BARCODE SYMBOLOGY	SSCC
BARCODE CONTENTS	GS1-128 (SSCC)

AGGREGATION DATA CAPTURE

PARENT-CHILD MAPPING AGGREGATION CAPTURE?

November 2017

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	No
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND UNIT DATA TO TRADING PARTNER?	As applicable
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?	No
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND AGGREGATION DATA TO TRADING PARTNER?	As applicable

AUTHENTICATION

WHO OFFERS DATA REPOSITORY FOR AUTHENTICATION?	Level 4
MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY?	Yes (Exports & Import)
DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT?	Yes
DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT?	Yes

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?	No
DOWNSTREAM TRADING PARTNER ACTIVITY REPORTED?	No

Source and Credit: This information is fully or partly based on the GS1 master document (all rights reserved). As GS1 does not control the content of the information, GS1 shall not be held liable, under any circumstance, if it differs from the master document.

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This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just a possible interpretation of information available in the public domain and that interpretation is subject to change. This information does not constitute legal advice.

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